CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE
FDA 510(k) clearance K121846 · decided 2012-11-20
Clearance details
- K-number
- K121846
- Device name
- CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE
- Applicant
- B.Braun Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-06-25
- Decision date
- 2012-11-20
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- BSP
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Allentown, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.