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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K102035
Device Name SLEEK OTW PTA CATHETERS
Applicant
ClearStream Technologies , Ltd.
Moyne Upper
Enniscorthy
Wexford,  IE
Applicant Contact FIONA NI MHULLAIN
Correspondent
ClearStream Technologies , Ltd.
Moyne Upper
Enniscorthy
Wexford,  IE
Correspondent Contact FIONA NI MHULLAIN
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received07/19/2010
Decision Date 12/01/2010
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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