The following data is part of a premarket notification filed by Convatec Inc with the FDA for Aquacel Ag Extra Hydrofiber Dressing With Silver And Strengthening Fiber.
| Device ID | K121275 |
| 510k Number | K121275 |
| Device Name: | AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER |
| Classification | Dressing, Wound, Drug |
| Applicant | CONVATEC INC 200 HEADQUARTERS PARK DRIVE Skillman, NJ 08558 |
| Contact | Katrina Fiedler |
| Correspondent | Katrina Fiedler CONVATEC INC 200 HEADQUARTERS PARK DRIVE Skillman, NJ 08558 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2012-04-27 |
| Decision Date | 2012-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00768455127481 | K121275 | 000 |
| 00768455145645 | K121275 | 000 |
| 00768455145652 | K121275 | 000 |
| 00768455145669 | K121275 | 000 |
| 00768455145676 | K121275 | 000 |
| 00768455145683 | K121275 | 000 |
| 00768455127375 | K121275 | 000 |
| 00768455127405 | K121275 | 000 |
| 00768455127436 | K121275 | 000 |
| 00768455127450 | K121275 | 000 |
| 00768455145638 | K121275 | 000 |