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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 K952114
Device Name KOOL GARD SINGLES 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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