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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
Recalls CDRH Recalls
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