Avante Micro Crystal System
FDA 510(k) K012231 · Jeneric/Pentron, Inc.
510(k) numberK012231
Submission
- Device name
- Avante Micro Crystal System
- Applicant
- Jeneric/Pentron, Inc.
Wallingford, CT, US - Received
- July 16, 2001
- Decision date
- August 23, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Avante Micro Crystal System cleared by the FDA?
Avante Micro Crystal System (K012231) received a 510(k) decision of Substantially Equivalent on August 23, 2001, 38 days after the submission was received.
What is the product code of K012231?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.