BARRIER SURGICAL GOWN

Gown, Surgical

SURGIKOS, INC.

The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Barrier Surgical Gown.

Pre-market Notification Details

Device IDK852870
510k NumberK852870
Device Name:BARRIER SURGICAL GOWN
ClassificationGown, Surgical
Applicant SURGIKOS, INC. P.O. BOX 130 Arlington,  TX  76010
ContactChristal O Fisher
CorrespondentChristal O Fisher
SURGIKOS, INC. P.O. BOX 130 Arlington,  TX  76010
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-08
Decision Date1985-07-23

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