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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, Cemented
510(k) Number K911684
Device Name BIOMET COBALT-CHROME FEMORAL COMPONENTS
Applicant
Biomet, Inc.
P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact PATRICIA M SANDBORN
Correspondent
Biomet, Inc.
P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact PATRICIA M SANDBORN
Regulation Number888.3350
Classification Product Code
JDI  
Date Received04/16/1991
Decision Date 06/27/1991
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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