FDA 510(k) Application Details - K180807

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K180807
Device Name	Instrument, Biopsy
Applicant	SpineSmith Holdings, LLC 4719 S Congress Ave Austin, TX 78745 US Other 510(k) Applications for this Company
Contact	Clifton (Chris) Naivar 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	03/28/2018
Decision Date	05/24/2018
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