TUBULICID BLUE LABEL
FDA 510(k) clearance K864050 · decided 1986-12-05
Clearance details
- K-number
- K864050
- Device name
- TUBULICID BLUE LABEL
- Applicant
- Dental Dimensions Supply Co.
- Decision
- Substantially Equivalent
- Date received
- 1986-10-16
- Decision date
- 1986-12-05
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- LBH
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Wantagh, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.