FDA 510(k) Application Details - K093718

Device Classification Name	Bulb, Inflation, For Endoscope   More FDA Info for this Device
510(K) Number	K093718
Device Name	Bulb, Inflation, For Endoscope
Applicant	ZUTRON MEDICAL LLC 9816 PFLUMM RD LENEXA, KS 66215 US Other 510(k) Applications for this Company
Contact	JORDAN HARTONG Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FCY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2009
Decision Date	02/22/2010
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