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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 K123771
Device Name KYPHON EXPRESS II INFLATABLE BONE TAMPS
Applicant
Medtronic
1221 Crossman Ave.
Sunnyvale,  CA  94089
Applicant Contact HETAL JAWAHAR THAKKER
Correspondent
Medtronic
1221 Crossman Ave.
Sunnyvale,  CA  94089
Correspondent Contact HETAL JAWAHAR THAKKER
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Codes
HXG   NDN  
Date Received12/07/2012
Decision Date 12/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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