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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, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K082468
Device Name APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)
Applicant
Omni Life Science, Inc.
175 Paramount Dr.
Raynham,  MA  02767
Applicant Contact WILLIAM MCCALLUM
Correspondent
Omni Life Science, Inc.
175 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact WILLIAM MCCALLUM
Regulation Number888.3390
Classification Product Code
KWY  
Date Received08/27/2008
Decision Date 02/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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