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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, Porous Uncemented
510(k) Number K101575
Device Name APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010
Applicant
Omnlife Science
50 O'Connell Way
East Taunton,  MA  02718
Applicant Contact RADHIKA PONDICHERRY
Correspondent
Omnlife Science
50 O'Connell Way
East Taunton,  MA  02718
Correspondent Contact RADHIKA PONDICHERRY
Regulation Number888.3358
Classification Product Code
LPH  
Date Received06/07/2010
Decision Date 06/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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