510(k) K083776

CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S by Corpak Medsystems — Product Code FPD

K083776 is an FDA 510(k) premarket notification submitted by Corpak Medsystems for the device "CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S". The FDA issued a decision of Substantially Equivalent on March 5, 2009. The device falls under product code FPD (Tube, Feeding), 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
March 5, 2009
Date Received
December 19, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Feeding
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type