After Loading Buchler

FDA 510(k) K832789 · Ellis Pharmaceutical Consulting, Inc.

Substantially Equivalent

510(k) numberK832789

Submission

Device name
After Loading Buchler
Applicant
Ellis Pharmaceutical Consulting, Inc.
Walker, MI, US
Received
August 15, 1983
Decision date
September 29, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JAQ – System, Applicator, Radionuclide, Remote-Controlled
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5700
Specialty
Radiology

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K241764Mould Probe MR SafeJAQ · Traditional Varian Medical Systems, Inc.01/10/2025SE
K242961Intraluminal Applicator SetJAQ · Traditional Varian Medical Systems11/26/2024SE
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More from Braxx Biotech Co., Ltd.

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K910936Empty I.V. ContainerKPE · Traditional 07/16/1991SE
K884233Quadroject(Tm)FMF · Traditional 01/30/1989SE
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K844180The MCP-70-SE SystemKQA · Traditional 02/01/1985SE

Questions and answers

When was After Loading Buchler cleared by the FDA?

After Loading Buchler (K832789) received a 510(k) decision of Substantially Equivalent on September 29, 1983, 45 days after the submission was received.

What is the product code of K832789?

The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.