Chemo Mini Spike Plus
FDA 510(k) K983794 · B. Braun of America, Inc.
510(k) numberK983794
Submission
- Device name
- Chemo Mini Spike Plus
- Applicant
- B. Braun of America, Inc.
Allentown, PA, US - Received
- October 27, 1998
- Decision date
- March 23, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Chemo Mini Spike Plus cleared by the FDA?
Chemo Mini Spike Plus (K983794) received a 510(k) decision of Substantially Equivalent on March 23, 1999, 147 days after the submission was received.
What is the product code of K983794?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.