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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 K152919
Device Name OMNI Skirted Heads
Applicant
Omni Life Science, Inc.
50 O'Connell Way
Suite 10
East Taunton,  MA  02718
Applicant Contact Vani Sindwani
Correspondent
Omni Life Science, Inc.
50 O'Connell Way
Suite 10
East Taunton,  MA  02718
Correspondent Contact Christina Flores
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received10/02/2015
Decision Date 03/10/2016
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
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