Sliding Reconstitution Device W/Admix Vialex Plast
FDA 510(k) K853830 · Travenol Laboratories, S.A.
510(k) numberK853830
Submission
- Device name
- Sliding Reconstitution Device W/Admix Vialex Plast
- Applicant
- Travenol Laboratories, S.A.
Deerfield, IL, US - Received
- September 13, 1985
- Decision date
- November 6, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was Sliding Reconstitution Device W/Admix Vialex Plast cleared by the FDA?
Sliding Reconstitution Device W/Admix Vialex Plast (K853830) received a 510(k) decision of Substantially Equivalent on November 6, 1985, 54 days after the submission was received.
What is the product code of K853830?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.