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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K012864
Device Name INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836
Applicant
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PLACE
NATICK,  MA  01760 -1537
Applicant Contact JAMES D MCMAHON
Correspondent
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PLACE
NATICK,  MA  01760 -1537
Correspondent Contact JAMES D MCMAHON
Regulation Number876.1075
Classification Product Code
FCG  
Date Received08/27/2001
Decision Date 10/24/2001
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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