MIRROR WARMER
FDA 510(k) clearance K781750 · decided 1979-01-17
Clearance details
- K-number
- K781750
- Device name
- MIRROR WARMER
- Applicant
- Arleton Technical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-10-16
- Decision date
- 1979-01-17
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- KAI
- 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 |
|---|---|---|
| ANTRUM & ATTIC MIRROR (K833601) | Microtek Medical, Inc. | 1984-01-03 |
| MIRROR TIP (K823915) | Treace Medical, Inc. | 1983-01-21 |
| BUCKINGHAM ATTIC & ANTRUM MIRROR (K822374) | Treace Medical, Inc. | 1982-09-09 |
| LARYNGEAL MIRRORS (K822261) | Kelleher Corp. | 1982-08-30 |
| HEAD MIRROR WITH HEADBAND (K822191) | Kelleher Corp. | 1982-08-20 |
| ATMOS MIRROR WARMER (K820354) | Jedmed Instrument Co. | 1982-03-01 |
| MIRROR, NASO-PHARYNX (K770054) | Welch Allyn, Inc. | 1977-01-18 |
| MIRROR, LARYNGEAL (K770053) | Welch Allyn, Inc. | 1977-01-18 |
Recalls involving this device
No recalls on record reference this clearance.