510(k) K041792

FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211 by Fresenius Medical Care North America — Product Code KDJ

K041792 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America for the device "FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211". The FDA issued a decision of Substantially Equivalent on September 24, 2004. The device falls under product code KDJ (Set, Administration, For Peritoneal Dialysis, Disposable), a Class II device regulated under 21 CFR 876.5630. Fresenius Medical Care North America has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2004
Date Received
July 2, 2004
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