DAY HEAR HOOK
FDA 510(k) clearance K780287 · decided 1978-02-27
Clearance details
- K-number
- K780287
- Device name
- DAY HEAR HOOK
- Applicant
- Edward Weck, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-02-21
- Decision date
- 1978-02-27
- Days to decision
- 6 days
- Clearance type
- Traditional
- Product code
- JYL
- 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 |
|---|---|---|
| JAKOBI SURG. INSTRUMENTS #7 10/43 (K834188) | Imm Enterprises , Ltd. | 1984-03-06 |
| MIRCOSURGICAL INSTRUMENTS (K822195) | Kelleher Corp. | 1982-08-25 |
| MICROSURGICAL EAR HOOK (K822166) | Kelleher Corp. | 1982-08-20 |
| DAY EAR HOOK (K772390) | Edward Weck, Inc. | 1978-01-17 |
Recalls involving this device
No recalls on record reference this clearance.