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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
Model 86-1014-0-XXXX, 86-1015-0-XXXX; 86-1018-0-XXXX
Device Name TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT
Original Applicant
TGM MEDICAL, INC.
5145 golden foothill parkway
suite 175 & 180
el dorado hills,  CA  95762
Original Contact prakash pai
Regulation Number888.3390
Classification Product Code
KWY  
Date Received05/21/2012
Decision Date 11/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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