FDA 510(k) Application Details - K081990

Device Classification Name	Jelly, Lubricating, For Transurethral Surgical Instrument   More FDA Info for this Device
510(K) Number	K081990
Device Name	Jelly, Lubricating, For Transurethral Surgical Instrument
Applicant	FARCO PHARMA GMBH 555 ELEVENTH STREET NW WASHINGTON, DC 20004-1304 US Other 510(k) Applications for this Company
Contact	SETH A MAILHOT Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/14/2008
Decision Date	12/05/2008
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