G-Coat
FDA 510(k) K052462 · GC America, Inc.
510(k) numberK052462
Submission
- Device name
- G-Coat
- Applicant
- GC America, Inc.
Alsip, IL, US - Received
- September 8, 2005
- Decision date
- October 20, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was G-Coat cleared by the FDA?
G-Coat (K052462) received a 510(k) decision of Substantially Equivalent on October 20, 2005, 42 days after the submission was received.
What is the product code of K052462?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.