GAUZE SPONGE STERILE

Gauze/sponge, Internal

SUDRECA SURGICAL DRESSINGS, INC.

The following data is part of a premarket notification filed by Sudreca Surgical Dressings, Inc. with the FDA for Gauze Sponge Sterile.

Pre-market Notification Details

Device IDK832173
510k NumberK832173
Device Name:GAUZE SPONGE STERILE
ClassificationGauze/sponge, Internal
Applicant SUDRECA SURGICAL DRESSINGS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEFQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-06
Decision Date1983-08-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.