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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K091299
Device Name SPECTRANETICS TURBO-TANDEM SYSTEM
Applicant
Spectranetics Corp.
9965 Federal Dr.
Colorado Springs,  CO  80921
Applicant Contact GRACIE MURGUIA
Correspondent
Spectranetics Corp.
9965 Federal Dr.
Colorado Springs,  CO  80921
Correspondent Contact GRACIE MURGUIA
Regulation Number870.1250
Classification Product Code
DQY  
Date Received05/04/2009
Decision Date 07/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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