Cleared Traditional

K821405 - MAGUN BASE I.V. POLE
(FDA 510(k) Clearance)

Jun 1982
Decision
36d
Days
Class 1
Risk

K821405 is an FDA 510(k) clearance for the MAGUN BASE I.V. POLE. This device is classified as a Stand, Infusion (Class I - General Controls, product code FOX).

Submitted by Manuco Manufacturing Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1982, 36 days after receiving the submission on May 11, 1982.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6990.

Submission Details

510(k) Number K821405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1982
Decision Date June 16, 1982
Days to Decision 36 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code FOX — Stand, Infusion
Device Class Class I - General Controls
CFR Regulation 21 CFR 880.6990