FDA 510(k) Application Details - K991323

Device Classification Name	Image, Illumination, Fiberoptic, For Endoscope   More FDA Info for this Device
510(K) Number	K991323
Device Name	Image, Illumination, Fiberoptic, For Endoscope
Applicant	SMITH & NEPHEW, INC. 160 DASCOMB RD. ANDOVER, MA 01810 US Other 510(k) Applications for this Company
Contact	DEBORAH CONNORS Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FFS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/19/1999
Decision Date	07/06/1999
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