Percutaneous Aspiration Biopsy Tray

FDA 510(k) K843885 · Applied Medical Devices, Inc.

Substantially Equivalent

510(k) numberK843885

Submission

Device name
Percutaneous Aspiration Biopsy Tray
Applicant
Applied Medical Devices, Inc.
Centennial, CO, US
Received
October 2, 1984
Decision date
December 19, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

No product code recorded.

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K840334Chemonucleolysis/Discography TrayFMI · Traditional 04/13/1984SE
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K833719Prepacell Thin Needle Aspiration TrayKOD · Traditional 01/25/1984SE
K802406Cytotran I Bone Marrow Aspiration SystemFMF · Traditional 01/15/1981SE
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Questions and answers

When was Percutaneous Aspiration Biopsy Tray cleared by the FDA?

Percutaneous Aspiration Biopsy Tray (K843885) received a 510(k) decision of Substantially Equivalent on December 19, 1984, 78 days after the submission was received.