Cleared Traditional

MICROSEPT 60/20

K890844 · Arbor Technologies, Inc. · General Hospital
Jun 1989
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K890844 is an FDA 510(k) clearance for the MICROSEPT 60/20, a Microfilter, Blood Transfusion (Class II — Special Controls, product code CAK), submitted by Arbor Technologies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on June 7, 1989, 106 days after receiving the submission on February 21, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K890844 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1989
Decision Date June 07, 1989
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code CAK — Microfilter, Blood Transfusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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