The following data is part of a premarket notification filed by Convatec, A Bristol-myers Squibb Co. with the FDA for Combiderm Acd.
Device ID | K973717 |
510k Number | K973717 |
Device Name: | COMBIDERM ACD |
Classification | Dressing, Wound And Burn, Occlusive |
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 | 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
COMBIDERM ACD 74721004 2048314 Live/Registered |
E.R. SQUIBB & SONS, LLC 1995-08-24 |