NON-WOVEN SPONGE

Gauze/sponge, Internal

MEDICAL INSIGHTS, INC.

The following data is part of a premarket notification filed by Medical Insights, Inc. with the FDA for Non-woven Sponge.

Pre-market Notification Details

Device IDK940901
510k NumberK940901
Device Name:NON-WOVEN SPONGE
ClassificationGauze/sponge, Internal
Applicant MEDICAL INSIGHTS, INC. 193 WHITEHALL AVE. Mystic,  CT  06355
ContactRobert J Caricato
CorrespondentRobert J Caricato
MEDICAL INSIGHTS, INC. 193 WHITEHALL AVE. Mystic,  CT  06355
Product CodeEFQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-24
Decision Date1994-03-31

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