SOFTIC 49
FDA 510(k) clearance K821230 · decided 1982-05-28
Clearance details
- K-number
- K821230
- Device name
- SOFTIC 49
- Applicant
- The Healthcare Group Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-04-27
- Decision date
- 1982-05-28
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- 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.