FDA 510(k) Application Details - K040961

Device Classification Name Snare, Flexible

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510(K) Number K040961
Device Name Snare, Flexible
Applicant UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY RD.
MENTOR, OH 44060 US
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Contact GRETCHEN Y COHEN
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Regulation Number 876.4300

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Classification Product Code FDI
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Date Received 04/13/2004
Decision Date 07/08/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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