FDA 510(k) Application Details - K140923

Device Classification Name Snare, Flexible

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510(K) Number K140923
Device Name Snare, Flexible
Applicant OVESCO ENDOSCOPY AG
DORFACKERSTRASSE 26
TUEBINGEN, BADEN-WUERTTEMBERG 72074 DE
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Contact TANJA LINZER
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Regulation Number 876.4300

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Classification Product Code FDI
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Date Received 04/10/2014
Decision Date 11/18/2014
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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