TBI TRAINER
FDA 510(k) clearance K840837 · decided 1985-03-25
Clearance details
- K-number
- K840837
- Device name
- TBI TRAINER
- Applicant
- Manico
- Decision
- Substantially Equivalent
- Date received
- 1984-02-24
- Decision date
- 1985-03-25
- Days to decision
- 395 days
- Clearance type
- Traditional
- Product code
- FEJ
- Device class
- 1
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.