FDA 510(k) Application Details - K010412

Device Classification Name	Endoscopic Grasping/Cutting Instrument, Non-Powered   More FDA Info for this Device
510(K) Number	K010412
Device Name	Endoscopic Grasping/Cutting Instrument, Non-Powered
Applicant	TELEMED SYSTEMS, INC. 8 KANE INDUSTRIAL DR. HUDSON, MA 01749 US Other 510(k) Applications for this Company
Contact	MICHAEL CARROLL Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2001
Decision Date	04/02/2001
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