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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K915740
Device Name DISPOSABLE O.R. TOWEL, STERILE
Applicant
American Threshold Industries, Inc.
240 Sardis Rd.
P.O. Box 1209
Enka,  NC  28728
Applicant Contact ROBERT T BAYER
Correspondent
American Threshold Industries, Inc.
240 Sardis Rd.
P.O. Box 1209
Enka,  NC  28728
Correspondent Contact ROBERT T BAYER
Regulation Number878.4370
Classification Product Code
KKX  
Date Received12/23/1991
Decision Date 06/22/1992
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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