Ear Knife-Various
FDA 510(k) K841006 · Premier Dental Products Co.
510(k) numberK841006
Submission
- Device name
- Ear Knife-Various
- Applicant
- Premier Dental Products Co.
Mchenry, IL, US - Received
- March 9, 1984
- Decision date
- May 30, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JYO – Knife, Ear
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code JYO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K910212 | Color Doppler Option to Ai 5200 Diag Ultraso SystJYO · Traditional | Acoustic Imaging Technologies Corp. | 07/11/1991SE |
| K840764 | Ear KnivesJYO · Traditional | Sharpoint, Inc. | 05/21/1984SE |
| K833602 | Roller Knife-Transverse -SagittalJYO · Traditional | Microtek Medical, Inc. | 01/03/1984SE |
| K823911 | Knife Blade TipJYO · Traditional | Treace Medical, Inc. | 01/21/1983SE |
| K772384 | Myringotomy KnifeJYO · Traditional | Edward Weck, Inc. | 01/17/1978SE |
| K772372 | Roller KnifeJYO · Traditional | Edward Weck, Inc. | 01/17/1978SE |
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| K062683 | Enamel Pro VarnishLBH · Traditional | 11/21/2006SE |
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Questions and answers
When was Ear Knife-Various cleared by the FDA?
Ear Knife-Various (K841006) received a 510(k) decision of Substantially Equivalent on May 30, 1984, 82 days after the submission was received.
What is the product code of K841006?
The FDA product code is JYO – Knife, Ear, a Class I (low risk) device regulated under 21 CFR 874.4420.