FDA 510(k) Application Details - K971615

Device Classification Name	Dilator, Esophageal   More FDA Info for this Device
510(K) Number	K971615
Device Name	Dilator, Esophageal
Applicant	TRI-MED SPECIALTIES, INC. 16309 WEST 108TH CIRCLE LENEXA, KS 66219 US Other 510(k) Applications for this Company
Contact	MIKE KNOTH 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	05/02/1997
Decision Date	07/24/1997
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