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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K926579
Device Name TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE
Applicant
Techmedica, Inc.
3760 Calle Tecate
Camarillo,  CA  93012
Applicant Contact CANDACE COBOS
Correspondent
Techmedica, Inc.
3760 Calle Tecate
Camarillo,  CA  93012
Correspondent Contact CANDACE COBOS
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/24/1992
Decision Date 04/06/1993
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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