MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22
FDA 510(k) clearance K080550 · decided 2008-06-10
Clearance details
- K-number
- K080550
- Device name
- MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22
- Applicant
- Minos Medical
- Decision
- Substantially Equivalent
- Date received
- 2008-02-28
- Decision date
- 2008-06-10
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- ODB
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.