K843559Substantially Equivalent

Kleenit by Qmed

Name: K843559 Kleenit by Qmed
Creator: Qmed, Inc.
Published: 1984-10-24
License: https://open.fda.gov/license/

Qmed, Inc., Louisville KY / Traditional, Substantially Equivalent

FDA source

K843559 is the FDA 510(k) clearance record for KLEENIT BY QMED, cleared for Qmed, Inc. on 1984-10-24. FDA records list 4 510(k) clearances for Qmed, Inc., from 1984-10-24 to 1987-09-30. As of 2026-09-10, FDA records show no recalls naming K843559.

Clearance record

Decision date: 1984-10-24
Received: 1984-09-10 (44 days to decision)
Review panel: Unknown
Applicant: Qmed, Inc. 3001 W. Kentucky St., Louisville KY
Third party review: No