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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K012605
Device Name REPROCESSED ATHROSCOPICS BURS
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 Number888.1100
Classification Product Code
HRX  
Date Received08/13/2001
Decision Date 11/07/2001
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
Recalls CDRH Recalls
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