S1 VAGINAL PACKING

Gauze/sponge, Internal

SURGICAL SPECIALTIES, INC.

The following data is part of a premarket notification filed by Surgical Specialties, Inc. with the FDA for S1 Vaginal Packing.

Pre-market Notification Details

Device IDK861443
510k NumberK861443
Device Name:S1 VAGINAL PACKING
ClassificationGauze/sponge, Internal
Applicant SURGICAL SPECIALTIES, INC. P.O. BOX 310 Reading,  PA  19607
ContactGeorge Erl
CorrespondentGeorge Erl
SURGICAL SPECIALTIES, INC. P.O. BOX 310 Reading,  PA  19607
Product CodeEFQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-17
Decision Date1986-05-06

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