510(k) K840837
- Device
- TBI TRAINER
- Applicant
- MANICO
- 510(k) number
- K840837
- Product code
- FEJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-03-25
- Date received
- 1984-02-24
- Regulation
- 876.1500
- Classification name
- Attachment, Binocular, For Endoscope
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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