The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Non-woven Compress.
Device ID | K980382 |
510k Number | K980382 |
Device Name: | NON-WOVEN COMPRESS |
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 For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-02 |
Decision Date | 1998-03-09 |
Summary: | summary |