TEFGEN - LS
FDA 510(k) clearance K965205 · decided 1997-04-30
Clearance details
- K-number
- K965205
- Device name
- TEFGEN - LS
- Applicant
- American Custom Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-26
- Decision date
- 1997-04-30
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- NPK
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Bozeman, MT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.