Panels › Gastroenterology, Urology › Product code FAF · Class 3
Prosthesis, Testicular
Regulation 876.3750
0510(k)s in 12 months (0 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in FAF
| Company | 510(k)s | Recalls |
|---|---|---|
| Coloplast Manufacturing US, LLC | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 27, 2010 | Coloplast Manufacturing US, LLC Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 Denmark.
Catalogue Number Description Part Number
450-1323 Extra Small 520600
450-1325 Sma Terminated |
FAF | None listed |
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