510(k) K832167

CORPAK VTR 300 ENTERNAL PUMP by Corpak Co. — Product Code FRN

K832167 is an FDA 510(k) premarket notification submitted by Corpak Co. for the device "CORPAK VTR 300 ENTERNAL PUMP". The FDA issued a decision of Substantially Equivalent on August 16, 1983. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Corpak Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1983
Date Received
July 5, 1983
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