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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 K073637
Device Name PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS
Applicant
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
P.O. BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact ELIZABETH WRAY
Correspondent
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
P.O. BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact ELIZABETH WRAY
Regulation Number888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   KWY   KWZ   LPH  
Date Received12/26/2007
Decision Date 03/20/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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