Cleared Traditional

K890997 - ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC)
(FDA 510(k) Clearance)

K890997 · Atlantic Wholesale, Inc. · Chemistry device

Mar 1989

Decision

29d

Days

Class 1

Risk

K890997 is an FDA 510(k) clearance for the ZAVOS DISPOSABLE FILTRATION COLUMN (ZDFC). This device is classified as a Resins, Ion-exchange (Class I - General Controls, product code KEA).

Submitted by Atlantic Wholesale, Inc. (Alpharetta, US). The FDA issued a Cleared decision on March 28, 1989, 29 days after receiving the submission on February 27, 1989.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2230.

Submission Details

510(k) Number	K890997 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 27, 1989
Decision Date	March 28, 1989
Days to Decision	29 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—