Royal Marsden Gold Grain Gun
FDA 510(k) K940119 · Best Industries
510(k) numberK940119
Submission
- Device name
- Royal Marsden Gold Grain Gun
- Applicant
- Best Industries
Springfield, VA, US - Received
- January 10, 1994
- Decision date
- December 30, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IWS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945515 | Coated Tungsten EyeshieldIWS · Traditional | Medtec, Inc. | 06/19/1995SE |
| K943011 | Tungsten EyeshieldIWS · Traditional | Medtec, Inc. | 12/23/1994SE |
| K934459 | Med-Genesis Patient Laser Eye ShieldIWS · Traditional | Med-Genesis, Inc. | 02/22/1994SE |
| K934362 | Nuclear Associates GlassersIWS · Traditional | Victoreen, Inc. | 11/12/1993SE |
| K920540 | Radiological Protective Eye ShieldIWS · Traditional | Burkhart Roentgen Intl., Inc. | 05/28/1992SE |
More from Burkhart Roentgen Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940121 | Implanters/Adjustable/Anderson's MarkersIWJ · Traditional | 12/30/1994SE |
| K933410 | Implant Applicators, Cartridges/Magazines, Implanters for Permanent Implant of…IWJ · Traditional | 12/30/1994SE |
| K932242 | Radioactive Samarium 145 Seeds/Sources #2341-2345KXK · Traditional | 07/27/1993SE |
| K930570 | Radioactive Palladium 103 Seeds/SourcesKXK · Traditional | 06/04/1993SE |
| K924290 | Best Industries Cartridge & GunIWJ · Traditional | 06/04/1993SE |
| K924261 | Radioactive CESIUM-131 Seeds/SourcesKXK · Traditional | 06/04/1993SE |
| K912170 | Radioactive IODINE-125 SourcesIWI · Traditional | 08/09/1991SE |
| K910862 | Various Template ApplicatorsIWJ · Traditional | 04/18/1991SE |
Questions and answers
When was Royal Marsden Gold Grain Gun cleared by the FDA?
Royal Marsden Gold Grain Gun (K940119) received a 510(k) decision of Substantially Equivalent on December 30, 1994, 354 days after the submission was received.
What is the product code of K940119?
The FDA product code is IWS – Shield, Eye, Radiological, a Class I (low risk) device regulated under 21 CFR 892.6500.