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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K914077
Device Name REPEL(TM) LITE CUT RESISTANT GLOVE LINERS
Applicant
Depuy-Raynham
P.O. Box 988
Warsaw,  IN  46580
Applicant Contact DAVID A KOTKOVETZ
Correspondent
Depuy-Raynham
P.O. Box 988
Warsaw,  IN  46580
Correspondent Contact DAVID A KOTKOVETZ
Regulation Number878.4040
Classification Product Code
LYU  
Date Received09/11/1991
Decision Date 12/02/1991
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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