IEC MEDSIGHT AND MEDBRIGHT
FDA 510(k) clearance K080809 · decided 2008-08-11
Clearance details
- K-number
- K080809
- Device name
- IEC MEDSIGHT AND MEDBRIGHT
- Applicant
- Innovative Endoscopy Components, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-03-21
- Decision date
- 2008-08-11
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- FET
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Ft. Lauderdale, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.