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. Device class: 2.
Clearance details
- Applicant
- Ossdsign AB
- Product code
- Code PJN
- Device class
- Class 2
- Regulation
- 21 CFR 882.5330
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Uppsala, SE
Recent devices under product code PJN
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