The following data is part of a premarket notification filed by Winn Hirsch & Assoc. with the FDA for Gauze Conversion Class Ii Sterile.
Device ID | K832213 |
510k Number | K832213 |
Device Name: | GAUZE CONVERSION CLASS II STERILE |
Classification | Gauze/sponge, Internal |
Applicant | WINN HIRSCH & ASSOC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EFQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-12 |
Decision Date | 1983-07-26 |