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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 K001134
Device Name GAZELLE BALLOON DILATATION CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick,  MA  01760
Applicant Contact JENNIFER BOLTON
Correspondent
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick,  MA  01760
Correspondent Contact JENNIFER BOLTON
Regulation Number870.1250
Classification Product Code
LIT  
Date Received04/10/2000
Decision Date 08/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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