EAR SPOON
FDA 510(k) clearance K822524 · decided 1982-09-09
Clearance details
- K-number
- K822524
- Device name
- EAR SPOON
- Applicant
- Kelleher Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-08-23
- Decision date
- 1982-09-09
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- KBD
- 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 |
|---|---|---|
| 13-320,13-330 TWO TYPES NAZAL SCISSORS-HEYMAN,BECK (K851763) | Artiberia | 1985-06-11 |
| SURGICAL SCISSORS (K791124) | Xomed, Inc. | 1979-06-27 |
Recalls involving this device
No recalls on record reference this clearance.