The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Convertors Primary Wound Dressing Ii.
Device ID | K822990 |
510k Number | K822990 |
Device Name: | CONVERTORS PRIMARY WOUND DRESSING II |
Classification | Dressing, Wound, Drug |
Applicant | AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-12 |
Decision Date | 1983-04-12 |