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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 K121509
Device Name TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT
Applicant
Tgm Medical, Inc.
5145 Golden Foothill Pkwy.
Suite 175 & 180
El Dorado,  CA  95762
Applicant Contact PRAKASH PAI
Correspondent
Tgm Medical, Inc.
5145 Golden Foothill Pkwy.
Suite 175 & 180
El Dorado,  CA  95762
Correspondent Contact PRAKASH PAI
Regulation Number888.3390
Classification Product Code
KWY  
Date Received05/21/2012
Decision Date 11/05/2012
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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