SPINAL INJECTION SYSTEM
FDA 510(k) clearance K083909 · decided 2009-03-18
Clearance details
- K-number
- K083909
- Device name
- SPINAL INJECTION SYSTEM
- Applicant
- Laurimed, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-12-30
- Decision date
- 2009-03-18
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- BSP
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.