K782154Substantially Equivalent

Colostomy Device, Maclet Magnetic

Name: K782154 Colostomy Device, Maclet Magnetic
Creator: Maclet Medical Devices, Inc.
Published: 1979-06-21
License: https://open.fda.gov/license/

Maclet Medical Devices, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K782154 is the FDA 510(k) clearance record for COLOSTOMY DEVICE, MACLET MAGNETIC, cleared for Maclet Medical Devices, Inc. on 1979-06-21. FDA records list one 510(k) clearance for Maclet Medical Devices, Inc. As of 2026-09-10, FDA records show no recalls naming K782154.

Clearance record

Decision date: 1979-06-21
Received: 1978-12-22 (181 days to decision)
Review panel: Unknown
Applicant: Maclet Medical Devices, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No