FDA 510(k) Application Details - K010610

Device Classification Name Endoscope Channel Accessory

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510(K) Number K010610
Device Name Endoscope Channel Accessory
Applicant BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick, MA 01760 US
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Contact LISA M QUAGLIA
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Regulation Number 876.1500

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Classification Product Code ODC
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Date Received 03/01/2001
Decision Date 03/27/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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