Radionics Sluijter-Mehta Cannula
FDA 510(k) K963577 · Radionics, Inc.
510(k) numberK963577
Submission
- Device name
- Radionics Sluijter-Mehta Cannula
- Applicant
- Radionics, Inc.
Burlington, MA, US - Received
- September 6, 1996
- Decision date
- November 21, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Radionics Sluijter-Mehta Cannula cleared by the FDA?
Radionics Sluijter-Mehta Cannula (K963577) received a 510(k) decision of Substantially Equivalent on November 21, 1996, 76 days after the submission was received.
What is the product code of K963577?
The FDA product code is GXD – Generator, Lesion, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 882.4400.