LAPOROTOMY SPONGE

Gauze/sponge, Internal

ABCO DEALERS, INC.

The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Laporotomy Sponge.

Pre-market Notification Details

Device IDK780806
510k NumberK780806
Device Name:LAPOROTOMY SPONGE
ClassificationGauze/sponge, Internal
Applicant ABCO DEALERS, 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 Received1978-05-10
Decision Date1978-06-22

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