FDA 510(k) Application Details - K983373

Device Classification Name	Dilator, Esophageal   More FDA Info for this Device
510(K) Number	K983373
Device Name	Dilator, Esophageal
Applicant	B. BRAUN/MCGAW 824 12TH AVE. BETHLEHEM, PA 18018-0027 US Other 510(k) Applications for this Company
Contact	MARK S ALSBERGE 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	09/24/1998
Decision Date	06/22/1999
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