OSTEOMED TRAM
FDA 510(k) clearance K963394 · decided 1996-11-14
Clearance details
- K-number
- K963394
- Device name
- OSTEOMED TRAM
- Applicant
- Osteomed Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-28
- Decision date
- 1996-11-14
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Irving, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.