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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cap, surgical
510(k) Number K953878
Device Name BOUFFANT CAP
Applicant
AMERICAN THRESHOLD INDUSTRIES, INC.
240 SARDIS RD.
P.O. BOX 1209
ENKA,  NC  28728
Applicant Contact GREGORY B SCOTT
Correspondent
AMERICAN THRESHOLD INDUSTRIES, INC.
240 SARDIS RD.
P.O. BOX 1209
ENKA,  NC  28728
Correspondent Contact GREGORY B SCOTT
Regulation Number878.4040
Classification Product Code
FYF  
Date Received08/16/1995
Decision Date 01/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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