Cleared Traditional

K820576 - MAINFLOW BACTERIA FILTER
(FDA 510(k) Clearance)

K820576 · Omnicon Medical Corp. · General Hospital

Mar 1982

Decision

15d

Days

Class 2

Risk

K820576 is an FDA 510(k) clearance for the MAINFLOW BACTERIA FILTER, a Filter, Bacterial, Breathing-circuit (Class II — Special Controls, product code CAH), submitted by Omnicon Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on March 18, 1982, 15 days after receiving the submission on March 3, 1982. This device falls under the General Hospital review panel. Regulated under 21 CFR 868.5260.

Submission Details

510(k) Number	K820576 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 03, 1982
Decision Date	March 18, 1982
Days to Decision	15 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—