510(k) K944750

CORFLO 300 PUMP by Corpak, Inc. — Product Code FRN

K944750 is an FDA 510(k) premarket notification submitted by Corpak, Inc. for the device "CORFLO 300 PUMP". The FDA issued a decision of PT on June 19, 1995. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Corpak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
PT ()
Decision Date
June 19, 1995
Date Received
September 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type