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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Plate, Fixation, Bone
510(k) Number K921458
Device Name TMP MICROPLATING 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 Number888.3030
Classification Product Code
HRS  
Date Received03/27/1992
Decision Date 07/17/1992
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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