BOUFFANT CAP

Cap, Surgical

AMERICAN THRESHOLD INDUSTRIES, INC.

The following data is part of a premarket notification filed by American Threshold Industries, Inc. with the FDA for Bouffant Cap.

Pre-market Notification Details

Device IDK953878
510k NumberK953878
Device Name:BOUFFANT CAP
ClassificationCap, Surgical
Applicant AMERICAN THRESHOLD INDUSTRIES, INC. 240 SARDIS RD. P.O. BOX 1209 Enka,  NC  28728
ContactGregory B Scott
CorrespondentGregory B Scott
AMERICAN THRESHOLD INDUSTRIES, INC. 240 SARDIS RD. P.O. BOX 1209 Enka,  NC  28728
Product CodeFYF  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-16
Decision Date1996-01-05

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