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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, femoral component, cemented, metal
510(k) Number K915787
Device Name STABILITY HIP STEM WITH POROCOAT
Applicant
DEPUY, INC.
P.O. BOX 988
WARSAW,  IN  46581 -0988
Applicant Contact DAVID KOTKOVETZ
Correspondent
DEPUY, INC.
P.O. BOX 988
WARSAW,  IN  46581 -0988
Correspondent Contact DAVID KOTKOVETZ
Regulation Number888.3360
Classification Product Code
JDG  
Date Received12/24/1991
Decision Date 04/29/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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