Jelenko Porcelain System PVS Procelain
FDA 510(k) K923717 · J.F. Jelenko & Co., Inc.
510(k) numberK923717
Submission
- Device name
- Jelenko Porcelain System PVS Procelain
- Applicant
- J.F. Jelenko & Co., Inc.
Armonk, NY, US - Received
- July 27, 1992
- Decision date
- March 16, 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 Jelenko Porcelain System PVS Procelain cleared by the FDA?
Jelenko Porcelain System PVS Procelain (K923717) received a 510(k) decision of Substantially Equivalent on March 16, 1993, 232 days after the submission was received.
What is the product code of K923717?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.