510(k) K124024

APD LUER-LOCK ADAPTER by Fresensius Medical Care North America — Product Code KDJ

K124024 is an FDA 510(k) premarket notification submitted by Fresensius Medical Care North America for the device "APD LUER-LOCK ADAPTER". The FDA issued a decision of Substantially Equivalent on September 19, 2013. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2013
Date Received
December 28, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type