LANO-E
FDA 510(k) clearance K111604 · decided 2012-06-08
Clearance details
- K-number
- K111604
- Device name
- LANO-E
- Applicant
- Ug Global Resources Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-08
- Decision date
- 2012-06-08
- Days to decision
- 366 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Costa Mesa, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.