Manifold with Extension Set
FDA 510(k) K982368 · Interpore Cross Intl.
510(k) numberK982368
Submission
- Device name
- Manifold with Extension Set
- Applicant
- Interpore Cross Intl.
Irvine, CA, US - Received
- July 7, 1998
- Decision date
- July 31, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| 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 Manifold with Extension Set cleared by the FDA?
Manifold with Extension Set (K982368) received a 510(k) decision of Substantially Equivalent on July 31, 1998, 24 days after the submission was received.
What is the product code of K982368?
The FDA product code is FMG – Stopcock, I.V. Set, a Class II (moderate risk) device regulated under 21 CFR 880.5440.