ROSEN'S STAPES NEEDLE EXPLORER
FDA 510(k) clearance K822277 · decided 1982-08-25
Clearance details
- K-number
- K822277
- Device name
- ROSEN'S STAPES NEEDLE EXPLORER
- Applicant
- Kelleher Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-07-29
- Decision date
- 1982-08-25
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- KAK
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core t recall (Z-0407-2013) | Vital Signs Colorado Inc. | 2012-11-20 |