ORALUBE
FDA 510(k) clearance K090457 · decided 2009-05-21
Clearance details
- K-number
- K090457
- Device name
- ORALUBE
- Applicant
- Pulpdent Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-02-23
- Decision date
- 2009-05-21
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- ONK
- Device class
- 1
- Regulation number
- 880.6375
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Watertown, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.