The following data is part of a premarket notification filed by Convatec, A Bristol-myers Squibb Co. with the FDA for Duoderm Hydroactive Gel.
| Device ID | K973806 |
| 510k Number | K973806 |
| Device Name: | DUODERM HYDROACTIVE GEL |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | CONVATEC, A BRISTOL-MYERS SQUIBB CO. 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Contact | Adrienne Mcnally |
| Correspondent | Adrienne Mcnally CONVATEC, A BRISTOL-MYERS SQUIBB CO. 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-06 |
| Decision Date | 1997-12-29 |
| Summary: | summary |