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 |