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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
510(k) Number K910807
Device Name KEANE UNI KNEE SYSTEM
Applicant
DEPUY, INC.
P.O. BOX 988
WARSAW,  IN  46581 -0988
Applicant Contact DAVID A KOTKOVETZ
Correspondent
DEPUY, INC.
P.O. BOX 988
WARSAW,  IN  46581 -0988
Correspondent Contact DAVID A KOTKOVETZ
Regulation Number888.3520
Classification Product Code
HSX  
Date Received02/26/1991
Decision Date 06/27/1991
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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