FDA 510(k) Application Details - K063309

Device Classification Name	Image, Illumination, Fiberoptic, For Endoscope   More FDA Info for this Device
510(K) Number	K063309
Device Name	Image, Illumination, Fiberoptic, For Endoscope
Applicant	TRUPHATEK INTERNATIONAL, LTD. 3460 POINTE CREEK CT. # 102 BONITA SPRINGS, FL 34134 US Other 510(k) Applications for this Company
Contact	PAUL DRYDEN 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	11/02/2006
Decision Date	01/12/2007
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