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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K094036
Device Name TURBO-TANDEM SYSTEM MODEL 472-110
Applicant
Spectranetics Corp.
9965 Federal Dr.
Colorado Springs,  CO  80921
Applicant Contact MICHAEL K HANDLEY
Correspondent
Spectranetics Corp.
9965 Federal Dr.
Colorado Springs,  CO  80921
Correspondent Contact MICHAEL K HANDLEY
Regulation Number870.4875
Classification Product Code
MCW  
Subsequent Product Code
DQY  
Date Received12/30/2009
Decision Date 01/25/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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