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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/ceramic/polymer, cemented or non-porous, uncemented
510(k) Number K111193
Device Name APEX ARC HIP STEM
Applicant
OMNILIFE SCIENCE INC.
50 O'CONNELL WAY
EAST TAUNTON,  MA  02718
Applicant Contact RADHIKA PONDICHERRY
Correspondent
OMNILIFE SCIENCE INC.
50 O'CONNELL WAY
EAST TAUNTON,  MA  02718
Correspondent Contact RADHIKA PONDICHERRY
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWY   LPH   MEH  
Date Received04/28/2011
Decision Date 06/27/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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