FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE
FDA 510(k) clearance K895245 · decided 1989-11-17
Clearance details
- K-number
- K895245
- Device name
- FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE
- Applicant
- Optimed Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-21
- Decision date
- 1989-11-17
- Days to decision
- 88 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
- 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.