The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons, Llc. with the FDA for Aquacel Hydrofiber Dressing And Aquacel Ag With Hydrofiber Silver Impregnated Antimicrobial Dressing.
Device ID | K063271 |
510k Number | K063271 |
Device Name: | AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING |
Classification | Dressing, Wound, Drug |
Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, LLC. 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
Contact | Marilyn Konicky |
Correspondent | Marilyn Konicky CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, LLC. 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 | 2006-10-30 |
Decision Date | 2007-04-16 |
Summary: | summary |