Lubecki Technical Holdings, Inc. · 89-08 · CANADA
For Lubecki Technical Holdings, 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 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 2026-09-30.
- 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
— 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, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html