Three-Way Stopcock Extension Set 20-SL
FDA 510(k) K800284 · Abbott Laboratories
510(k) numberK800284
Submission
- Device name
- Three-Way Stopcock Extension Set 20-SL
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- February 8, 1980
- Decision date
- February 26, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMG – Stopcock, I.V. Set
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K141254 | Elcam Stopcocks and ManifoldsFMG · Special | Elcam Medical Acal | 07/30/2014SE |
| K123084 | Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold…FMG · Traditional | Elcam Medical Acal | 05/23/2013SE |
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Questions and answers
When was Three-Way Stopcock Extension Set 20-SL cleared by the FDA?
Three-Way Stopcock Extension Set 20-SL (K800284) received a 510(k) decision of Substantially Equivalent on February 26, 1980, 18 days after the submission was received.
What is the product code of K800284?
The FDA product code is FMG – Stopcock, I.V. Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.