The One and Only Fashion Beauty Group, Inc. · 89-08 · CANADA
For The One and Only Fashion Beauty Group, Inc., import alert is 89-08; country is CANADA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product code is 86 H - - PK Tonograph | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort; date published is 09/16/2009; address is 74 Simcoe Road , Kettleby, Ontario, CANADA, verified against its source on 2026-09-30.
- Firm
- The One and Only Fashion Beauty Group, Inc. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CANADA verified
- Address
- 74 Simcoe Road , Kettleby, Ontario, CANADA verified
- Date published
- 09/16/2009 verified
- Product code
- 86 H - - PK Tonograph | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort each item verified
- FDA notes
- Decorative Contact Lenses. 4/7/2006. | Decorative Contact Lenses. 4/7/2006. | Decorative Contact Lenses. 4/7/2006. | Decorative Contact Lenses. 4/7/2006. | Decorative Contact Lenses. 4/7/2006. | Decorative Contact Lenses. 4/7/2006. | Decorative Contact Lenses. 4/7/2006. | Decorative Contact Lenses. 4/7/2006. | Decorative Contact Lenses. 4/7/2006. each item verified
What the source says
The One and Only Fashion Beauty Group, Inc. Date Published : 09/16/2009 74 Simcoe Road , Kettleby, Ontario, CANADA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and FDA notes
86 H - - PK Tonograph Date Published: 09/16/2009 Notes: Decorative Contact Lenses. 4/7/2006. 86 H - - QD Lens, Contact (Other Material) - Daily Date Published: 09/16/2009 Notes: Decorative Contact Lenses. 4/7/2006. 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 09/16/2009 Notes: Decorative Contact Lenses. 4/7/2006. 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 09/16/2009 Notes: Decorative Contact Lenses. 4/7/2006. 86 M - - UW Lens, Contact (Orthokeratology) Date Published: 09/16/2009 Notes: Decorative Contact Lenses. 4/7/2006. 86 M - - VN Lens, Contact (Disposable) Date Published: 09/16/2009 Notes: Decorative Contact Lenses. 4/7/2006. 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear Date Published: 09/16/2009 Notes: Decorative Contact Lenses. 4/7/2006. 86 N - - CZ Lens, Contact, for Color Vision Deficiency Date Published: 09/16/2009 Notes: Decorative Contact Lenses. 4/7/2006. 86 N - - IC Lens, Contact, for Reading Discomfort Date Published: 09/16/2009 Notes: Decorative Contact Lenses. 4/7/2006.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html