FDA 510(k) Application Details - K961846

Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology

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510(K) Number K961846
Device Name Endoscopic Injection Needle, Gastroenterology-Urology
Applicant BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK, MA 01760-1537 US
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Contact LISA M QUAGLIA
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Regulation Number 876.1500

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Classification Product Code FBK
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Date Received 05/13/1996
Decision Date 07/15/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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