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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 uncemented acetabular component)
510(k) Number K070274
Device Name ECHO BI-METRIC PRESS-FIT STEMS
Original Applicant
BIOMET MANUFACTURING CORP.
po box 587
warsaw,  IN  46581 0587
Original Contact susan alexander
Regulation Number888.3330
Classification Product Code
KWA  
Date Received01/29/2007
Decision Date 04/03/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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