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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/Polymer, Cemented
510(k) Number K911058
Device Name TECHMEDICA CAD/CAM CUSTOM HIP
Applicant
Techmedica, Inc.
3760 Calle Tecate
Camarillo,  CA  93012
Applicant Contact RICHARD CUDWORTH
Correspondent
Techmedica, Inc.
3760 Calle Tecate
Camarillo,  CA  93012
Correspondent Contact RICHARD CUDWORTH
Regulation Number888.3350
Classification Product Code
JDI  
Date Received03/08/1991
Decision Date 02/23/1993
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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