LAPAROTOMY SPONGE

Gauze/sponge, Internal

QUALTEX, INC.

The following data is part of a premarket notification filed by Qualtex, Inc. with the FDA for Laparotomy Sponge.

Pre-market Notification Details

Device IDK780818
510k NumberK780818
Device Name:LAPAROTOMY SPONGE
ClassificationGauze/sponge, Internal
Applicant QUALTEX, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeEFQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-05-17
Decision Date1978-06-22

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