Jewel Cast III
FDA 510(k) K003037 · Jeneric/Pentron, Inc.
510(k) numberK003037
Submission
- Device name
- Jewel Cast III
- Applicant
- Jeneric/Pentron, Inc.
Wallingford, CT, US - Received
- September 29, 2000
- Decision date
- December 5, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Jewel Cast III cleared by the FDA?
Jewel Cast III (K003037) received a 510(k) decision of Substantially Equivalent on December 5, 2000, 67 days after the submission was received.
What is the product code of K003037?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.