FDA 510(k) Application Details - K093329

Device Classification Name Endoscope Channel Accessory

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510(K) Number K093329
Device Name Endoscope Channel Accessory
Applicant N.M. BEALE CO. INC.
5 WHITCOMB AVENUE
AYER, MA 01432 US
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Contact PAMELA PAPINEAU
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Regulation Number 876.1500

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Classification Product Code ODC
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Date Received 10/26/2009
Decision Date 02/16/2010
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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