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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K012648
Device Name REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES
Applicant
ALLIANCE MEDICAL CORP.
10232 SOUTH 51ST ST.
PHOENIX,  AZ  85044
Applicant Contact DON SELVEY
Correspondent
ALLIANCE MEDICAL CORP.
10232 SOUTH 51ST ST.
PHOENIX,  AZ  85044
Correspondent Contact DON SELVEY
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Codes
JEC   KTW  
Date Received08/13/2001
Decision Date 06/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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