510(k) K100365

FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV by Corpak Medsystems — Product Code KNT

K100365 is an FDA 510(k) premarket notification submitted by Corpak Medsystems for the device "FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS MODEL 20-4300AIV". The FDA issued a decision of Substantially Equivalent on May 20, 2010. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Corpak Medsystems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2010
Date Received
February 12, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type