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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
510(k) Number K021721
Device Name EQUALIZER BALLOON 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
DQY  
Date Received05/24/2002
Decision Date 06/20/2002
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
Recalls CDRH Recalls
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