Isorod PD-103 Implant, Model ATI-PD-103
FDA 510(k) K020683 · Ati Medical, Inc.
510(k) numberK020683
Submission
- Device name
- Isorod PD-103 Implant, Model ATI-PD-103
- Applicant
- Ati Medical, Inc.
San Diego, CA, US - Received
- March 4, 2002
- Decision date
- December 17, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Isorod PD-103 Implant, Model ATI-PD-103 cleared by the FDA?
Isorod PD-103 Implant, Model ATI-PD-103 (K020683) received a 510(k) decision of Substantially Equivalent on December 17, 2002, 288 days after the submission was received.
What is the product code of K020683?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.