FDA 510(k) Application Details - K001328

Device Classification Name	Obturator, For Endoscope   More FDA Info for this Device
510(K) Number	K001328
Device Name	Obturator, For Endoscope
Applicant	NOVASYS MEDICAL, INC. 687 NO. PASTORIA AVE. SUNNYVALE, CA 94086 US Other 510(k) Applications for this Company
Contact	THOMAS C WEHMAN Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FEC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2000
Decision Date	07/17/2000
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