Lubecki Technical Holdings, Inc. · 89-08 · CANADA
For Lubecki Technical Holdings, Inc. · 89-08 · CANADA, import alert is 89-08; 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)"; country is CANADA; product is John's Only Pump Enlargement Pump | John's Only Pump Enlargement Pump; product code is 78 L - - KY Device, External Penile Rigidity | 78 N - - HU Extender, Penile, Mechanical; date published is 08/26/2012; address is 435 Saint-Vallier St , Granby, Quebec CANADA, verified against its source on 2026-09-16.
- Firm
- Lubecki Technical Holdings, 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
- 435 Saint-Vallier St , Granby, Quebec CANADA verified
- Date published
- 08/26/2012 verified
- Product code
- 78 L - - KY Device, External Penile Rigidity | 78 N - - HU Extender, Penile, Mechanical each item verified
- Product
- John's Only Pump Enlargement Pump | John's Only Pump Enlargement Pump each item verified
- FDA notes
- Class II | Class II each item verified
What the source says
Lubecki Technical Holdings, Inc. Date Published : 08/26/2012 435 Saint-Vallier St , Granby, Quebec CANADA 78 L - - KY Device, External Penile Rigidity Date Published: 08/26/2012 Desc: John's Only Pump Enlargement Pump Notes: Class II 78 N - - HU Extender, Penile, Mechanical Date Published: 08/26/2012 Desc: John's Only Pump Enlargement Pump Notes: Class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.