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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 K123632
Device Name 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035
Applicant
SPECTRANETICS CORP.
9965 Federal Drive
Colorado Springs,  CO  80921
Applicant Contact CHRISTINE GODLESKI
Correspondent
SPECTRANETICS CORP.
9965 Federal Drive
Colorado Springs,  CO  80921
Correspondent Contact CHRISTINE GODLESKI
Regulation Number870.4875
Classification Product Code
MCW  
Date Received11/23/2012
Decision Date 01/25/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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