SPEC Model M13
FDA 510(k) K161395 · Source Production and Equipment Co., Inc.
510(k) numberK161395
Submission
- Device name
- SPEC Model M13
- Applicant
- Source Production and Equipment Co., Inc.
Saint Rose, LA, US - Received
- May 19, 2016
- Decision date
- July 6, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was SPEC Model M13 cleared by the FDA?
SPEC Model M13 (K161395) received a 510(k) decision of Substantially Equivalent on July 6, 2016, 48 days after the submission was received.
What is the product code of K161395?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.