FDA 510(k) Application Details - K201244

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K201244
Device Name	Instrument, Biopsy
Applicant	TransMed7, LLC 117 Solana Road Portola Valley, CA 94028 US Other 510(k) Applications for this Company
Contact	James Vetter 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	05/08/2020
Decision Date	08/07/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review