Ultragold
FDA 510(k) K923817 · J.F. Jelenko & Co., Inc.
510(k) numberK923817
Submission
- Device name
- Ultragold
- Applicant
- J.F. Jelenko & Co., Inc.
Armonk, NY, US - Received
- July 30, 1992
- Decision date
- March 11, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Ultragold cleared by the FDA?
Ultragold (K923817) received a 510(k) decision of Substantially Equivalent on March 11, 1993, 224 days after the submission was received.
What is the product code of K923817?
The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.