The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Duoderm Cgf Control Gel Formula Dressing.
| Device ID | K973632 |
| 510k Number | K973632 |
| Device Name: | DUODERM CGF CONTROL GEL FORMULA DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 100 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Contact | Adrienne Mcnally |
| Correspondent | Adrienne Mcnally CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 100 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Product Code | MGP |
| 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 | 1997-09-24 |
| Decision Date | 1997-12-22 |
| Summary: | summary |