The following data is part of a premarket notification filed by Convatec, A Bristol-myers Squibb Co. with the FDA for Aquacel Hydrofiber Wound Dressing.
| Device ID | K982116 |
| 510k Number | K982116 |
| Device Name: | AQUACEL HYDROFIBER WOUND DRESSING |
| Classification | Bandage, Liquid |
| Applicant | CONVATEC, A BRISTOL-MYERS SQUIBB CO. 100 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Contact | Ameer Ally |
| Correspondent | Ameer Ally CONVATEC, A BRISTOL-MYERS SQUIBB CO. 100 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-16 |
| Decision Date | 1998-09-08 |
| Summary: | summary |