Product code KAI
- Device name
- Mirror, 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 |
|---|---|---|---|
| K833601 | ANTRUM & ATTIC MIRROR | Microtek Medical, Inc. | 1984-01-03 |
| K823915 | MIRROR TIP | Treace Medical, Inc. | 1983-01-21 |
| K822374 | BUCKINGHAM ATTIC & ANTRUM MIRROR | Treace Medical, Inc. | 1982-09-09 |
| K822261 | LARYNGEAL MIRRORS | Kelleher Corp. | 1982-08-30 |
| K822191 | HEAD MIRROR WITH HEADBAND | Kelleher Corp. | 1982-08-20 |
| K820354 | ATMOS MIRROR WARMER | Jedmed Instrument Co. | 1982-03-01 |
| K781750 | MIRROR WARMER | Arleton Technical Products, Inc. | 1979-01-17 |
| K770053 | MIRROR, LARYNGEAL | Welch Allyn, Inc. | 1977-01-18 |
| K770054 | MIRROR, NASO-PHARYNX | Welch Allyn, Inc. | 1977-01-18 |
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| 10381780107965 | MicroFrance® | INTEGRA MICROFRANCE | 2018-01-12 |