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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gown, Isolation, Surgical
510(k) Number K952115
Device Name BARRIER GOWN, KOOL-GARD BACKLESS GOWN
Applicant
American Threshold Industries, Inc.
P.O. Box 1209
240 Sardis Rd.
Enka,  NC  28728
Applicant Contact GREGORY B SCOTT
Correspondent
American Threshold Industries, Inc.
P.O. Box 1209
240 Sardis Rd.
Enka,  NC  28728
Correspondent Contact GREGORY B SCOTT
Regulation Number878.4040
Classification Product Code
FYC  
Date Received05/05/1995
Decision Date 09/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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