Radionics Siphon Limiting Device (SLD)
FDA 510(k) K962990 · Radionics, Inc.
510(k) numberK962990
Submission
- Device name
- Radionics Siphon Limiting Device (SLD)
- Applicant
- Radionics, Inc.
Burlington, MA, US - Received
- August 1, 1996
- Decision date
- October 23, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K993594 | Conformax MMLC VR1IYE · Special | 12/15/1999SE |
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Questions and answers
When was Radionics Siphon Limiting Device (SLD) cleared by the FDA?
Radionics Siphon Limiting Device (SLD) (K962990) received a 510(k) decision of Substantially Equivalent on October 23, 1996, 83 days after the submission was received.
What is the product code of K962990?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.