FDA 510(k) Application Details - K093796

Device Classification Name	More FDA Info for this Device
510(K) Number	K093796
Device Name	ASEPT PERITONEAL DRAINAGE SYSTEM
Applicant	PFM MEDICAL, INC 2605 TEMPLE HEIGHTS DRIVE SUITE A OCEANSIDE, CA 92056 US Other 510(k) Applications for this Company
Contact	SALVADORE PALOMARES Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2009
Decision Date	02/26/2010
Decision	SESK - SUBST EQUIV - KIT
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