The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Ha Absorbent Wound Dressing.
Device ID | K984388 |
510k Number | K984388 |
Device Name: | HA ABSORBENT WOUND DRESSING |
Classification | Dressing, Wound, Collagen |
Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 100 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
Contact | Adriienne Mcnally |
Correspondent | Adriienne Mcnally CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 100 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
Product Code | KGN |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-12-08 |
Decision Date | 1999-03-03 |
Summary: | summary |