Mirror, Laryngeal
FDA 510(k) K770053 · Welch Allyn, Inc.
510(k) numberK770053
Submission
- Device name
- Mirror, Laryngeal
- Applicant
- Welch Allyn, Inc.
Mchenry, IL, US - Received
- January 10, 1977
- Decision date
- January 18, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KAI – Mirror, Ent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code KAI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K833601 | Antrum & Attic MirrorKAI · Traditional | Microtek Medical, Inc. | 01/03/1984SE |
| K823915 | Mirror TipKAI · Traditional | Treace Medical, Inc. | 01/21/1983SE |
| K822374 | Buckingham Attic & Antrum MirrorKAI · Traditional | Treace Medical, Inc. | 09/09/1982SE |
| K822261 | Laryngeal MirrorsKAI · Traditional | Kelleher Corp. | 08/30/1982SE |
| K822191 | Head Mirror with HeadbandKAI · Traditional | Kelleher Corp. | 08/20/1982SE |
| K820354 | Atmos Mirror WarmerKAI · Traditional | Jedmed Instrument Co. | 03/01/1982SE |
| K781750 | Mirror WarmerKAI · Traditional | Arleton Technical Products, Inc. | 01/17/1979SE |
| K770054 | Mirror, Naso-PharynxKAI · Traditional | Welch Allyn, Inc. | 01/18/1977SE |
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Questions and answers
When was Mirror, Laryngeal cleared by the FDA?
Mirror, Laryngeal (K770053) received a 510(k) decision of Substantially Equivalent on January 18, 1977, 8 days after the submission was received.
What is the product code of K770053?
The FDA product code is KAI – Mirror, Ent, a Class I (low risk) device regulated under 21 CFR 874.4420.