LFRE INDIRECT LARYNGOSCOPE
FDA 510(k) clearance K023004 · decided 2003-01-28
Clearance details
- K-number
- K023004
- Device name
- LFRE INDIRECT LARYNGOSCOPE
- Applicant
- Astralite Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-09
- Decision date
- 2003-01-28
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- EOB
- Device class
- 2
- Regulation number
- 874.4760
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Van Nuys, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.