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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 K903697
Device Name HAWAIIAN SUPRACONDYLAR PLATE
Applicant
Medpac
25768 Parada Dr.
Valencia,  CA  91355
Applicant Contact DAVID MEDOFF
Correspondent
Medpac
25768 Parada Dr.
Valencia,  CA  91355
Correspondent Contact DAVID MEDOFF
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/15/1990
Decision Date 01/15/1991
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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