The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons, L.l.c. with the FDA for Aquacel Hydrofiber Wound Dressing And Ag Hydrofiber Dressing.
Device ID | K080383 |
510k Number | K080383 |
Device Name: | AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING |
Classification | Dressing, Wound, Drug |
Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
Contact | Marilyn Konicky |
Correspondent | Marilyn Konicky CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2008-02-12 |
Decision Date | 2008-05-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00768455145621 | K080383 | 000 |
10768455106742 | K080383 | 000 |