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 & Border.
| Device ID | K925991 | 
| 510k Number | K925991 | 
| Device Name: | DUODERM CGF CONTROL GEL FORMULA DRESSING & BORDER | 
| Classification | Bandage, Liquid | 
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 | 
| Contact | Steven R Peltier | 
| Correspondent | Steven R Peltier CONVATEC, A DIVISION OF E.R. SQUIBB & SONS P.O. BOX 4000 Princeton, NJ 08540 | 
| Product Code | KMF | 
| CFR Regulation Number | 880.5090 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1992-11-25 | 
| Decision Date | 1993-10-28 |