General Utility Tray System

FDA 510(k) K843884 · Applied Medical Devices, Inc.

Substantially Equivalent

510(k) numberK843884

Submission

Device name
General Utility Tray System
Applicant
Applied Medical Devices, Inc.
Mchenry, IL, US
Received
October 2, 1984
Decision date
December 13, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

No product code recorded.

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K842591Ultrasound Probe Covers-SterileIYO · Traditional 07/23/1984SE
K833720Transthoracic/Transabdominal-TrayGDM · Traditional 05/30/1984SE
K840334Chemonucleolysis/Discography TrayFMI · Traditional 04/13/1984SE
K833438Prepacell-Sterile-Bone Marrow AspirKDD · Traditional 02/09/1984SE
K833719Prepacell Thin Needle Aspiration TrayKOD · Traditional 01/25/1984SE
K802406Cytotran I Bone Marrow Aspiration SystemFMF · Traditional 01/15/1981SE
K791660Prepacell-Bone Marrow SamplerFMF · Traditional 09/12/1979SE

Questions and answers

When was General Utility Tray System cleared by the FDA?

General Utility Tray System (K843884) received a 510(k) decision of Substantially Equivalent on December 13, 1984, 72 days after the submission was received.