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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 K851823
Device Name DISPOSABLE ISOLATION GOWN
Applicant
American Threshold Industries, Inc.
P.O. Box 1209
240 Sardis Rd.
Enka,  NC  28728
Applicant Contact ROBERT T BAYER
Correspondent
American Threshold Industries, Inc.
P.O. Box 1209
240 Sardis Rd.
Enka,  NC  28728
Correspondent Contact ROBERT T BAYER
Regulation Number878.4040
Classification Product Code
FYC  
Date Received04/26/1985
Decision Date 05/17/1985
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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