Biscover LV
FDA 510(k) K043168 · Bisco, Inc.
510(k) numberK043168
Submission
- Device name
- Biscover LV
- Applicant
- Bisco, Inc.
Schaumburg, IL, US - Received
- November 16, 2004
- Decision date
- February 1, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Biscover LV cleared by the FDA?
Biscover LV (K043168) received a 510(k) decision of Substantially Equivalent on February 1, 2005, 77 days after the submission was received.
What is the product code of K043168?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.