The following data is part of a premarket notification filed by Sudreca Surgical Dressings, Inc. with the FDA for Gauze Sponge Non-sterile.
Device ID | K832174 |
510k Number | K832174 |
Device Name: | GAUZE SPONGE NON-STERILE |
Classification | Gauze/sponge, Internal |
Applicant | SUDRECA SURGICAL DRESSINGS, INC. 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 | 1983-07-06 |
Decision Date | 1983-08-12 |