510(k) K925654

CD HOME DIALYSERVICE HEMODIALYSIS TRAY by Cd Medical, Inc. — Product Code KOC

K925654 is an FDA 510(k) premarket notification submitted by Cd Medical, Inc. for the device "CD HOME DIALYSERVICE HEMODIALYSIS TRAY". The FDA issued a decision of Substantially Equivalent (kit, denovo) on March 30, 1994. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Cd Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
March 30, 1994
Date Received
November 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Blood Circuit, Hemodialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type