FDA 510(k) Application Details - K191315

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K191315
Device Name	Instrument, Biopsy
Applicant	Remington Medical, Inc. 6830 Meadowridge Court Alpharetta, GA 30005 US Other 510(k) Applications for this Company
Contact	Caitlin Senter 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	05/15/2019
Decision Date	07/12/2019
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	N
Expedited Review