FDA 510(k) Application Details - K050403

Device Classification Name Mini Endoscope, Gastroenterology-Urology

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510(K) Number K050403
Device Name Mini Endoscope, Gastroenterology-Urology
Applicant BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PLACE
NATICK, MA 01760-1537 US
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Contact KATHLEEN MORAHAN
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Regulation Number 876.1500

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Classification Product Code ODF
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Date Received 02/17/2005
Decision Date 03/04/2005
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 Y
Expedited Review



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