FDA 510(k) Application Details - K990935

Device Classification Name	Dilator, Esophageal   More FDA Info for this Device
510(K) Number	K990935
Device Name	Dilator, Esophageal
Applicant	PILLING WECK SURGICAL 420 DELAWARE DR. FORT WASHINGTON, PA 19034 US Other 510(k) Applications for this Company
Contact	ELIZABETH LAZARO 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	03/19/1999
Decision Date	05/17/1999
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