FDA 510(k) Application Details - K121604

Device Classification Name	Anoscope And Accessories   More FDA Info for this Device
510(K) Number	K121604
Device Name	Anoscope And Accessories
Applicant	OBP CORPORATION 360 MERRIMACK STREET BUILDING 9 LAWRENCE, MA 01843 US Other 510(k) Applications for this Company
Contact	JASON SWIFT 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	06/01/2012
Decision Date	07/27/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review