3M I-125 Seeds in Absorbable Carrier
FDA 510(k) K801748 · 3M Company
510(k) numberK801748
Submission
- Device name
- 3M I-125 Seeds in Absorbable Carrier
- Applicant
- 3M Company
White City, OR, US - Received
- July 28, 1980
- Decision date
- December 18, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special | 06/27/2024SE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special | 06/27/2024SE |
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| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 05/18/2023SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 09/23/2022SE |
Questions and answers
When was 3M I-125 Seeds in Absorbable Carrier cleared by the FDA?
3M I-125 Seeds in Absorbable Carrier (K801748) received a 510(k) decision of Substantially Equivalent on December 18, 1980, 143 days after the submission was received.
What is the product code of K801748?
The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.