SMALL MASTOID RETRACTOR
FDA 510(k) clearance K870758 · decided 1987-03-04
Clearance details
- K-number
- K870758
- Device name
- SMALL MASTOID RETRACTOR
- Applicant
- Treace Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-02-26
- Decision date
- 1987-03-04
- Days to decision
- 6 days
- Clearance type
- Traditional
- Product code
- KAL
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Memphis, TN, 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 |
|---|---|---|
| ADJUSTABLE FORK RETRACTOR (K833604) | Microtek Medical, Inc. | 1984-01-03 |
| RING HANDLE & RETRACTORS (K772381) | Edward Weck, Inc. | 1978-01-17 |
| ALLPORT MASTOID RETRACTORS (K772392) | Edward Weck, Inc. | 1978-01-17 |
| CONVERSE ALTAR RETRACTOR (K760851) | V. Mueller O.V. Baxter Healthcare Corp. | 1977-03-10 |
Recalls involving this device
No recalls on record reference this clearance.