Surface Coat
FDA 510(k) K063228 · Kuraray America, Inc.
510(k) numberK063228
Submission
- Device name
- Surface Coat
- Applicant
- Kuraray America, Inc.
New York, NY, US - Received
- October 25, 2006
- Decision date
- December 8, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Surface Coat cleared by the FDA?
Surface Coat (K063228) received a 510(k) decision of Substantially Equivalent on December 8, 2006, 44 days after the submission was received.
What is the product code of K063228?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.