FDA 510(k) Application Details - K081004

Device Classification Name	Colonoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K081004
Device Name	Colonoscope And Accessories, Flexible/Rigid
Applicant	STRYKER GI 1420 LAKESIDE PARKWAY, #110 FLOWER MOUND, TX 75028 US Other 510(k) Applications for this Company
Contact	TIFFANI ROGERS Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/08/2008
Decision Date	05/02/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review