ALGI-BAND
FDA 510(k) clearance K951237 · decided 1995-04-10
Clearance details
- K-number
- K951237
- Device name
- ALGI-BAND
- Applicant
- Health-Dent Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-20
- Decision date
- 1995-04-10
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- ELW
- Device class
- 2
- Regulation number
- 872.3660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Northlake, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.