Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory Anatomical Model Modified, Cranial PSI Accessory Plastic Drawing Guide, Cranial PSI Accessory Cranial Implant Trial— 510(k) K190523
Substantially EquivalentOssdsign AB
FDA 510(k) clearance K190523 for Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory Anatomical Model Modified, Cranial PSI Accessory Plastic Drawing Guide, Cranial PSI Accessory Cranial Implant Trial, Substantially Equivalent on 2019-10-10. Applicant: Ossdsign AB.
Clearance details
- Applicant
- Ossdsign AB
- Product code
- Code PJN
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Uppsala, SE
Data sourced from openFDA. This site is unofficial and independent of the FDA.