VSP Cranial System
FDA 510(k) clearance K151285 · decided 2016-09-23
Clearance details
- K-number
- K151285
- Device name
- VSP Cranial System
- Applicant
- 3D Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-05-14
- Decision date
- 2016-09-23
- Days to decision
- 498 days
- Clearance type
- Traditional
- Product code
- PPT
- Device class
- 2
- Regulation number
- 882.4310
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Golden, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.