Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate— 510(k) K191475
Substantially EquivalentNobel Biocare AB
FDA 510(k) clearance K191475 for Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate, Substantially Equivalent on 2019-08-29. Applicant: Nobel Biocare AB. Device class: 2.
Clearance details
- Applicant
- Nobel Biocare AB
- Product code
- Code KCT
- Device class
- Class 2
- Regulation
- 21 CFR 880.6850
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goteborg, SE
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