Handling & Cutting Device for IRIDIUM-192 Wire Pin
FDA 510(k) K890191 · Amersham Corp.
510(k) numberK890191
Submission
- Device name
- Handling & Cutting Device for IRIDIUM-192 Wire Pin
- Applicant
- Amersham Corp.
Arlington Heights, IL, US - Received
- January 18, 1989
- Decision date
- February 6, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Handling & Cutting Device for IRIDIUM-192 Wire Pin cleared by the FDA?
Handling & Cutting Device for IRIDIUM-192 Wire Pin (K890191) received a 510(k) decision of Substantially Equivalent on February 6, 1989, 19 days after the submission was received.
What is the product code of K890191?
The FDA product code is IWJ – System, Applicator, Radionuclide, Manual, a Class I (low risk) device regulated under 21 CFR 892.5650.