The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Convatec Odor Control Wound Dressing.
Device ID | K972530 |
510k Number | K972530 |
Device Name: | CONVATEC ODOR CONTROL WOUND DRESSING |
Classification | Bandage, Liquid |
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 | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-07 |
Decision Date | 1997-10-01 |
Summary: | summary |