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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 K060959
Device Name SYMMETRY BALLOON DILATATION CATHETER
Applicant
Boston Scientific Corporation
Two Scimed Place
Maple Grove,  MN  55311
Applicant Contact ANGELA BYLAND
Correspondent
Boston Scientific Corporation
Two Scimed Place
Maple Grove,  MN  55311
Correspondent Contact ANGELA BYLAND
Regulation Number870.1250
Classification Product Code
LIT  
Date Received04/07/2006
Decision Date 04/12/2006
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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