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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 K131820
Device Name AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G
Applicant
CAREFUSION
75 NORTH FAIRWAY DRIVE
VERNON HILLS,  IL  60061
Applicant Contact JOY GREIDANUS
Correspondent
CAREFUSION
75 NORTH FAIRWAY DRIVE
VERNON HILLS,  IL  60061
Correspondent Contact JOY GREIDANUS
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
NDN  
Date Received06/20/2013
Decision Date 10/04/2013
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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