Contour Flex Valves (Regular & Small)
FDA 510(k) K954285 · Radionics, Inc.
510(k) numberK954285
Submission
- Device name
- Contour Flex Valves (Regular & Small)
- Applicant
- Radionics, Inc.
Burlington, MA, US - Received
- September 14, 1995
- Decision date
- January 26, 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 Contour Flex Valves (Regular & Small) cleared by the FDA?
Contour Flex Valves (Regular & Small) (K954285) received a 510(k) decision of Substantially Equivalent on January 26, 1996, 134 days after the submission was received.
What is the product code of K954285?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.