The following data is part of a premarket notification filed by Convatec, A Bristol-myers Squibb Co. with the FDA for Duoderm Extra Thin Cgf Dressing.
Device ID | K973716 |
510k Number | K973716 |
Device Name: | DUODERM EXTRA THIN CGF DRESSING |
Classification | Dressing, Wound And Burn, Occlusive |
Applicant | CONVATEC, A BRISTOL-MYERS SQUIBB CO. 211 AMERICAN AVE. Greensboro, NC 27409 |
Contact | Adrienne Mcnally |
Correspondent | Adrienne Mcnally CONVATEC, A BRISTOL-MYERS SQUIBB CO. 211 AMERICAN AVE. Greensboro, NC 27409 |
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 | 1997-09-29 |
Decision Date | 1997-12-17 |
Summary: | summary |