BARRIER GOWN, KOOL-GARD BACKLESS GOWN

Gown, Isolation, Surgical

AMERICAN THRESHOLD INDUSTRIES, INC.

The following data is part of a premarket notification filed by American Threshold Industries, Inc. with the FDA for Barrier Gown, Kool-gard Backless Gown.

Pre-market Notification Details

Device IDK952115
510k NumberK952115
Device Name:BARRIER GOWN, KOOL-GARD BACKLESS GOWN
ClassificationGown, Isolation, Surgical
Applicant AMERICAN THRESHOLD INDUSTRIES, INC. P.O. BOX 1209 240 SARDIS ROAD Enka,  NC  28728
ContactGregory B Scott
CorrespondentGregory B Scott
AMERICAN THRESHOLD INDUSTRIES, INC. P.O. BOX 1209 240 SARDIS ROAD Enka,  NC  28728
Product CodeFYC  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-05
Decision Date1995-09-25

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