510(k) K821405

MAGUN BASE I.V. POLE by Manuco Manufacturing Co., Inc. — Product Code FOX

K821405 is an FDA 510(k) premarket notification submitted by Manuco Manufacturing Co., Inc. for the device "MAGUN BASE I.V. POLE". The FDA issued a decision of Substantially Equivalent on June 16, 1982. The device falls under product code FOX (Stand, Infusion), a Class I device regulated under 21 CFR 880.6990. Manuco Manufacturing Co., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1982
Date Received
May 11, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stand, Infusion
Device Class
Class I
Regulation Number
880.6990
Review Panel
HO
Submission Type