Cleared Traditional

K801008 - MULTI-AD FLUID DISPENSING PUMP MP-3000
(FDA 510(k) Clearance)

Jun 1980
Decision
35d
Days
Class 1
Risk

K801008 is an FDA 510(k) clearance for the MULTI-AD FLUID DISPENSING PUMP MP-3000. This device is classified as a Dispenser, Liquid Medication (Class I - General Controls, product code KYX).

Submitted by Burron Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on June 2, 1980, 35 days after receiving the submission on April 28, 1980.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6430.

Submission Details

510(k) Number K801008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1980
Decision Date June 02, 1980
Days to Decision 35 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code KYX — Dispenser, Liquid Medication
Device Class Class I - General Controls
CFR Regulation 21 CFR 880.6430

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