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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 K925420
Device Name TECHMEDICA STANDARD BIPOLAR SYSTEM
Applicant
Techmedica, Inc.
3760 Calle Tecate
Camarillo,  CA  93012
Applicant Contact DAVE SAMSON
Correspondent
Techmedica, Inc.
3760 Calle Tecate
Camarillo,  CA  93012
Correspondent Contact DAVE SAMSON
Regulation Number888.3390
Classification Product Code
KWY  
Date Received10/27/1992
Decision Date 09/28/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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