OSTEOTAPE
FDA 510(k) clearance K090794 · decided 2009-12-10
Clearance details
- K-number
- K090794
- Device name
- OSTEOTAPE
- Applicant
- Impladent , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-03-24
- Decision date
- 2009-12-10
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- NPM
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Hollis, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.