The following data is part of a premarket notification filed by Winn Hirsch & Assoc. with the FDA for Gauze Conversion Class I-non-sterile.
Device ID | K832214 |
510k Number | K832214 |
Device Name: | GAUZE CONVERSION CLASS I-NON-STERILE |
Classification | Gauze/sponge, Internal |
Applicant | WINN HIRSCH & ASSOC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
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 |