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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, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K902246
Device Name AMK UNIVERSAL FEMORAL COMPONENT
Applicant
DEPUY, INC.
P.O. BOX 988
WARSAW,  IN  46581 -0988
Applicant Contact MELINDA A WRIGHT
Correspondent
DEPUY, INC.
P.O. BOX 988
WARSAW,  IN  46581 -0988
Correspondent Contact MELINDA A WRIGHT
Regulation Number888.3560
Classification Product Code
JWH  
Date Received05/18/1990
Decision Date 08/09/1990
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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