DEFOGGING AND CLEANING SOLUTION- FLO-X
FDA 510(k) clearance K102452 · decided 2010-12-23
Clearance details
- K-number
- K102452
- Device name
- DEFOGGING AND CLEANING SOLUTION- FLO-X
- Applicant
- Minimally Invasive Devices, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-08-27
- Decision date
- 2010-12-23
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- OCT
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lake Butler, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.