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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K935646
Device Name FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM
Applicant
Biodynamic Technologies, Inc.
1000 Burnett Ave.
Suite 250
Concord,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
Biodynamic Technologies, Inc.
1000 Burnett Ave.
Suite 250
Concord,  CA  94520
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received11/23/1993
Decision Date 03/09/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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