Needle, Burron Filter
FDA 510(k) K790061 · National Patent Development Corp.
510(k) numberK790061
Submission
- Device name
- Needle, Burron Filter
- Applicant
- National Patent Development Corp.
Mchenry, IL, US - Received
- January 10, 1979
- Decision date
- February 16, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K962425 | Bonopty Coaxial Bone Biopsy System with Eccentric DRILL(10-1072,3,4)GAA · Traditional | Radi Medical Systems AB | 09/11/1996SE |
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| K940025 | Manan Bone Marrow Harvest NeedlesGAA · Traditional | Manan Medical Products, Inc. | 02/25/1994SE |
More from Manan Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K843974 | Variable Temperature Cautery DeviceGEI · Traditional | 02/26/1985SE |
| K832699 | Hydron Wound Dressing Fast Seat KitFRO · Traditional | 04/27/1984SE |
| K822793 | Pio Root Canal IndicatorEIL · Traditional | 10/22/1982SE |
| K820028 | Zeon Composite Resin Light Cure SysEBF · Traditional | 03/11/1982SE |
| K820006 | Zeon Composite Resin SystemEBF · Traditional | 01/22/1982SE |
| K811446 | Hydron Wound Dressing KitKMF · Traditional | 06/12/1981SE |
| K801484 | Root Canal Filling Applicator NeedlesEIC · Traditional | 07/21/1980SE |
| K801483 | Mark IV SyringeEIC · Traditional | 07/21/1980SE |
| K801482 | Hydron Root Canal Filling MaterialKIF · Traditional | 07/21/1980SE |
| K792136 | Hypo-Allergenic Plastic TapeFPX · Traditional | 01/16/1980SE |
Questions and answers
When was Needle, Burron Filter cleared by the FDA?
Needle, Burron Filter (K790061) received a 510(k) decision of Substantially Equivalent on February 16, 1979, 37 days after the submission was received.
What is the product code of K790061?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.