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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 K102645
Device Name WILLOW/ELM PTA BALLOON DILATATION CATHETER
Applicant
Creagh Medical, Ltd.
5 Timber Ln.
North Reading,  MA  01864
Applicant Contact MAUREEN O'CONNELL
Correspondent
Creagh Medical, Ltd.
5 Timber Ln.
North Reading,  MA  01864
Correspondent Contact MAUREEN O'CONNELL
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received09/13/2010
Decision Date 12/10/2010
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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