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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 K905024
Device Name TMP MANDIBULAR COMPRESSION SYSTEM
Applicant
Techmedica, Inc.
3760 Calle Tecate
Camarillo,  CA  93012
Applicant Contact JEFFREY CHEEK
Correspondent
Techmedica, Inc.
3760 Calle Tecate
Camarillo,  CA  93012
Correspondent Contact JEFFREY CHEEK
Regulation Number888.3030
Classification Product Code
HRS  
Date Received11/07/1990
Decision Date 06/24/1991
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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