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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K940743
Device Name UHMWPE COMPONENTS-CHANGE IN PACKAGING
Applicant
DEPUY, INC.
700 ORTHOPAEDIC DR.
P.O. BOX 988
WARSAW,  IN  46581 -0988
Applicant Contact DAVID A KOTKOVETZ
Correspondent
DEPUY, INC.
700 ORTHOPAEDIC DR.
P.O. BOX 988
WARSAW,  IN  46581 -0988
Correspondent Contact DAVID A KOTKOVETZ
Regulation Number888.3390
Classification Product Code
KWY  
Subsequent Product Codes
HRY   JDB   KWI   LZN  
Date Received02/16/1994
Decision Date 09/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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