Radioactive Samarium 145 Seeds/Sources #2341-2345
FDA 510(k) K932242 · Best Industries
510(k) numberK932242
Submission
- Device name
- Radioactive Samarium 145 Seeds/Sources #2341-2345
- Applicant
- Best Industries
Springfield, VA, US - Received
- May 7, 1993
- Decision date
- July 27, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Isoray Medical, Inc.
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| K940121 | Implanters/Adjustable/Anderson's MarkersIWJ · Traditional | 12/30/1994SE |
| K940119 | Royal Marsden Gold Grain GunIWS · Traditional | 12/30/1994SE |
| K933410 | Implant Applicators, Cartridges/Magazines, Implanters for Permanent Implant of…IWJ · Traditional | 12/30/1994SE |
| 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 Radioactive Samarium 145 Seeds/Sources #2341-2345 cleared by the FDA?
Radioactive Samarium 145 Seeds/Sources #2341-2345 (K932242) received a 510(k) decision of Substantially Equivalent on July 27, 1993, 81 days after the submission was received.
What is the product code of K932242?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.