LOW FLOW OSV II HYDROCEPHALUS VALVE
FDA 510(k) clearance K042192 · decided 2004-09-02
Clearance details
- K-number
- K042192
- Device name
- LOW FLOW OSV II HYDROCEPHALUS VALVE
- Applicant
- Integra Neurosciences Implants S.A.
- Decision
- Substantially Equivalent
- Date received
- 2004-08-12
- Decision date
- 2004-09-02
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- JXG
- Device class
- 2
- Regulation number
- 882.5550
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Planisboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.