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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, Cutting/Scoring
510(k) Number K062387
Device Name SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
Applicant
Boston Scientific
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact ANGIE BYLAND
Correspondent
Boston Scientific
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact ANGIE BYLAND
Regulation Number870.1250
Classification Product Code
PNO  
Date Received08/15/2006
Decision Date 10/05/2006
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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