LANCETS FOR EAR SURGERY
FDA 510(k) clearance K822279 · decided 1982-08-25
Clearance details
- K-number
- K822279
- Device name
- LANCETS FOR EAR SURGERY
- 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
- KTG
- 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 |
|---|---|---|
| ENT KNIFE HANDLES (K822280) | Kelleher Corp. | 1982-08-30 |
| KNIVES, ENT (K822205) | Kelleher Corp. | 1982-08-30 |
| TONSIL DISSECTORS (K822187) | Kelleher Corp. | 1982-08-24 |
| KNIFE HANDLE (K822203) | Kelleher Corp. | 1982-08-20 |
Recalls involving this device
No recalls on record reference this clearance.