The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Nonwoven Pad.
Device ID | K980720 |
510k Number | K980720 |
Device Name: | NONWOVEN PAD |
Classification | Bandage, Liquid |
Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 100 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
Contact | Ameer Ally |
Correspondent | Ameer Ally 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 | 1998-02-24 |
Decision Date | 1998-04-15 |
Summary: | summary |