FDA 510(k) Application Details - K973584

Device Classification Name	Prosthesis, Esophageal   More FDA Info for this Device
510(K) Number	K973584
Device Name	Prosthesis, Esophageal
Applicant	MEDTECH INSTRUMENTS 6271 BURY DR. EDEN PRAIRIE, MN 55346 US Other 510(k) Applications for this Company
Contact	JOHN R DALPEE Other 510(k) Applications for this Contact
Regulation Number	878.3610   More FDA Info for this Regulation Number
Classification Product Code	ESW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/22/1997
Decision Date	01/09/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review