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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, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K953337
Device Name BETA HIP PROSTHESIS
Applicant
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581
Applicant Contact ANGIE IDE
Correspondent
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581
Correspondent Contact ANGIE IDE
Regulation Number888.3358
Classification Product Code
LPH  
Date Received07/17/1995
Decision Date 01/22/1996
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
Recalls CDRH Recalls
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