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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, semi-constrained, cemented, metal/polymer
510(k) Number K944538
Device Name GAS PLASMA STERILIZATION
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 Number888.3530
Classification Product Code
HRY  
Subsequent Product Codes
HSX   JDB   JDI   JWH   KWT  
Date Received09/15/1994
Decision Date 09/26/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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