VARIOUS TYPES OF ENT ELEVATORS
FDA 510(k) clearance K822270 · decided 1982-08-16
Clearance details
- K-number
- K822270
- Device name
- VARIOUS TYPES OF ENT ELEVATORS
- Applicant
- Kelleher Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-07-29
- Decision date
- 1982-08-16
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- KAD
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ELEVATOR (K841356) | Treace Medical, Inc. | 1984-07-18 |
| ENT ELEVATORS (K822190) | Kelleher Corp. | 1982-08-16 |
| BOIES NASAL FRACTURE ELEVATOR (K772391) | Edward Weck, Inc. | 1978-01-17 |
| DINGMAN ZYGOMA ELEVATOR (K772399) | Edward Weck, Inc. | 1978-01-17 |
Recalls involving this device
No recalls on record reference this clearance.