FDA 510(k) Application Details - K974493

Device Classification Name	Gastroscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K974493
Device Name	Gastroscope And Accessories, Flexible/Rigid
Applicant	FIEGERT-ENDOTECH MEDIZINTECHNIK GMBH GAENSAECKER 42 TUTTLINGEN D-78532 DE Other 510(k) Applications for this Company
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/28/1997
Decision Date	03/31/1998
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