CESIUM-137 Afterloading System /Gyn.Bra.
FDA 510(k) K800320 · Amersham Corp.
510(k) numberK800320
Submission
- Device name
- CESIUM-137 Afterloading System /Gyn.Bra.
- Applicant
- Amersham Corp.
Walker, MI, US - Received
- February 12, 1980
- Decision date
- March 25, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was CESIUM-137 Afterloading System /Gyn.Bra. cleared by the FDA?
CESIUM-137 Afterloading System /Gyn.Bra. (K800320) received a 510(k) decision of Substantially Equivalent on March 25, 1980, 42 days after the submission was received.
What is the product code of K800320?
The FDA product code is IWJ – System, Applicator, Radionuclide, Manual, a Class I (low risk) device regulated under 21 CFR 892.5650.