FDA 510(k) Application Details - K152474

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K152474
Device Name	Instrument, Biopsy
Applicant	Avitus Orthopaedics Inc. 400 Farmington Ave Suite R1717 Farmington, CT 06032 US Other 510(k) Applications for this Company
Contact	Maxim Budyansky 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	08/31/2015
Decision Date	10/23/2015
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