The following data is part of a premarket notification filed by Convatec Inc with the FDA for Aquacel Ag Foam Hydrofiber Foam Dressing With Silver, Adhesive And Non Adhesive.
| Device ID | K123481 |
| 510k Number | K123481 |
| Device Name: | AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE |
| 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 | No |
| Date Received | 2012-11-13 |
| Decision Date | 2013-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00768455133468 | K123481 | 000 |
| 00768455123797 | K123481 | 000 |
| 00076845512374 | K123481 | 000 |
| 00768455123773 | K123481 | 000 |
| 00768455123780 | K123481 | 000 |
| 00768455123803 | K123481 | 000 |
| 00768455123810 | K123481 | 000 |
| 00768455123872 | K123481 | 000 |
| 00768455123889 | K123481 | 000 |
| 00768455123896 | K123481 | 000 |
| 00768455123902 | K123481 | 000 |
| 00768455127153 | K123481 | 000 |
| 00768455129126 | K123481 | 000 |
| 00768455129164 | K123481 | 000 |
| 00768455129201 | K123481 | 000 |
| 00007684551231 | K123481 | 000 |