FACEBOW FOR BALANCE ARTICULATOR
FDA 510(k) clearance K830775 · decided 1983-04-28
Clearance details
- K-number
- K830775
- Device name
- FACEBOW FOR BALANCE ARTICULATOR
- Applicant
- Almore Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-11
- Decision date
- 1983-04-28
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- KCR
- Device class
- 1
- Regulation number
- 872.3220
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.