FDA 510(k) Application Details - K954614

Device Classification Name	Endoscope, Ac-Powered And Accessories   More FDA Info for this Device
510(K) Number	K954614
Device Name	Endoscope, Ac-Powered And Accessories
Applicant	NORTH EOS INDUSTRIES, INC. 54, LANE 1, BEEN ST. P.O. BOX 22, TUNG SHIH TAICHUNG HSIEN 423 TW Other 510(k) Applications for this Company
Contact	SARA CHEN Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	GCP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/05/1995
Decision Date	04/10/1996
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