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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 K942027
Device Name IMPACT CO-CR 1-PIECE FEMORAL COMPONENT
Applicant
BIOMET, INC.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact PATRICIA BERES
Correspondent
BIOMET, INC.
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact PATRICIA BERES
Regulation Number888.3360
Classification Product Code
JDG  
Date Received04/26/1994
Decision Date 09/19/1994
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
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