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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 K123782
Device Name PARAGON HIP SYSTEM
Applicant
Global Manufacturing Technology
1331 H St. NW
Washington,  DC  20005
Applicant Contact HOLLACE S RHODES
Correspondent
Global Manufacturing Technology
1331 H St. NW
Washington,  DC  20005
Correspondent Contact HOLLACE S RHODES
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received12/10/2012
Decision Date 03/14/2013
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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