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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
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