FDA 510(k) Application Details - K171973

Device Classification Name Forceps, Biopsy, Electric

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510(K) Number K171973
Device Name Forceps, Biopsy, Electric
Applicant Wilson-Cook Medical, Inc.
4900 Bethania Station Road
Winston-Salem, NC 27105 US
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Contact Ashley Howard
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Regulation Number 876.4300

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Classification Product Code KGE
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Date Received 06/30/2017
Decision Date 03/21/2018
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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