FDA 510(k) Application Details - K133393

Device Classification Name	Anoscope And Accessories   More FDA Info for this Device
510(K) Number	K133393
Device Name	Anoscope And Accessories
Applicant	APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 US Other 510(k) Applications for this Company
Contact	FRANS VANDENBROEK Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FER Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2013
Decision Date	01/02/2014
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