FDA 510(k) Application Details - K160423

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K160423
Device Name	Kit, Needle, Biopsy
Applicant	Corbin Clinical Resources, LLC 12234 Williams Road Cumberland, MD 21502 US Other 510(k) Applications for this Company
Contact	Kenneth K. Kleinhenz Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	FCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2016
Decision Date	09/02/2016
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