FDA 510(k) Application Details - K202012

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K202012
Device Name	Instrument, Biopsy
Applicant	Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 US Other 510(k) Applications for this Company
Contact	Gwendolyn P. Payne Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	KNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/21/2020
Decision Date	08/18/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review