FDA 510(k) Application Details - K083275

Device Classification Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)   More FDA Info for this Device
510(K) Number	K083275
Device Name	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant	MAX ENDOSCOPY INC. 1410 HIGHLAND ROAD, SUITE 6 MACEDONIA, OH 44056 US Other 510(k) Applications for this Company
Contact	MICHAEL WOLF Other 510(k) Applications for this Contact
Regulation Number	876.4300   More FDA Info for this Regulation Number
Classification Product Code	KNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/2008
Decision Date	06/09/2009
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