Product code KAL
- Device name
- Retractor, Ent
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.4420
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K870758 | SMALL MASTOID RETRACTOR | Treace Medical, Inc. | 1987-03-04 |
| K833604 | ADJUSTABLE FORK RETRACTOR | Microtek Medical, Inc. | 1984-01-03 |
| K772381 | RING HANDLE & RETRACTORS | Edward Weck, Inc. | 1978-01-17 |
| K772392 | ALLPORT MASTOID RETRACTORS | Edward Weck, Inc. | 1978-01-17 |
| K760851 | CONVERSE ALTAR RETRACTOR | V. Mueller O.V. Baxter Healthcare Corp. | 1977-03-10 |
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|---|---|---|---|
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| 07898506816422 | Quinelato | Schobell Industrial Ltda | 2023-01-09 |
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