OSTEOTAPE— 510(k) K090794
Substantially EquivalentImpladent , Ltd.
FDA 510(k) clearance K090794 for OSTEOTAPE, Substantially Equivalent on 2009-12-10. Applicant: Impladent , Ltd.. Device class: 2.
Clearance details
- Applicant
- Impladent , Ltd.
- Product code
- Code NPM
- Device class
- Class 2
- Regulation
- 21 CFR 872.3930
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hollis, NY, US
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