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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic guidewire, gastroenterology-urology
510(k) Number K141820
Device Name JAGWIRE HIGH PERFORMANCE GUIDWIRE
Applicant
BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Applicant Contact ALLISON BAILLIE
Correspondent
BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Correspondent Contact ALLISON BAILLIE
Regulation Number876.1500
Classification Product Code
OCY  
Date Received07/07/2014
Decision Date 10/21/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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