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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Shoe, Operating-Room
510(k) Number K894383
Device Name DISPOSABLE SHOE COVER
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 Number878.4040
Classification Product Code
FXP  
Date Received07/17/1989
Decision Date 09/12/1989
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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