LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC
FDA 510(k) clearance K121248 · decided 2013-12-13
Clearance details
- K-number
- K121248
- Device name
- LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC
- Applicant
- Moller Medical GmbH
- Decision
- Substantially Equivalent
- Date received
- 2012-04-25
- Decision date
- 2013-12-13
- Days to decision
- 597 days
- Clearance type
- Traditional
- Product code
- JXG
- Device class
- 2
- Regulation number
- 882.5550
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Corona, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.