Uromed Brachytheraphy IODINE-125 Sources
FDA 510(k) K982226 · Uromed Corp.
510(k) numberK982226
Submission
- Device name
- Uromed Brachytheraphy IODINE-125 Sources
- Applicant
- Uromed Corp.
Needham, MA, US - Received
- June 24, 1998
- Decision date
- May 13, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Uromed Brachytheraphy IODINE-125 Sources cleared by the FDA?
Uromed Brachytheraphy IODINE-125 Sources (K982226) received a 510(k) decision of Substantially Equivalent on May 13, 1999, 323 days after the submission was received.
What is the product code of K982226?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.