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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K943071
Device Name THE TITANIUM FIXATION SYSTEM
Applicant
Biomedics
6081 San Rafael Dr..
Buena Park,  CA  90620
Applicant Contact CAROL E JONES
Correspondent
Biomedics
6081 San Rafael Dr..
Buena Park,  CA  90620
Correspondent Contact CAROL E JONES
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
GXR  
Date Received06/28/1994
Decision Date 01/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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