FDA 510(k) Application Details - K061937

Device Classification Name	Dilator, Esophageal   More FDA Info for this Device
510(K) Number	K061937
Device Name	Dilator, Esophageal
Applicant	COOK ENDOSCOPY 4900 BETHANIA STATION RD. WINSTON-SALEM, NC 27105 US Other 510(k) Applications for this Company
Contact	MABEL L HUNTER 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	07/10/2006
Decision Date	12/01/2006
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