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 |