FDA 510(k) Application Details - K082995

Device Classification Name	Dilator, Esophageal   More FDA Info for this Device
510(K) Number	K082995
Device Name	Dilator, Esophageal
Applicant	SAFESTITCH MEDICAL 4400 BISCAYNE BLVD. MIAMI, FL 33137 US Other 510(k) Applications for this Company
Contact	MARIO ARBESU Other 510(k) Applications for this Contact
Regulation Number	876.5365   More FDA Info for this Regulation Number
Classification Product Code	KNQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/08/2008
Decision Date	02/06/2009
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