FDA 510(k) Application Details - K083556

Device Classification Name	Ligator, Esophageal   More FDA Info for this Device
510(K) Number	K083556
Device Name	Ligator, Esophageal
Applicant	SCANDIMED INTERNATIONAL 29 FRIGATE ST. JAMESTOWN, RI 02835 US Other 510(k) Applications for this Company
Contact	STEPHEN M PAGE Other 510(k) Applications for this Contact
Regulation Number	876.4400   More FDA Info for this Regulation Number
Classification Product Code	MND Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2008
Decision Date	02/19/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review