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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dress, Surgical
510(k) Number K910941
Device Name LIFELINER SURGICAL GLOVE
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
FYE  
Date Received03/06/1991
Decision Date 05/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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