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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 K914702
Device Name STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS
Applicant
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Applicant Contact A KOTKOVETZ
Correspondent
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Correspondent Contact A KOTKOVETZ
Regulation Number878.4040
Classification Product Code
FXP  
Date Received10/18/1991
Decision Date 01/29/1993
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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