Vulcan
FDA 510(k) K953594 · Cmp Industries, LLC
510(k) numberK953594
Submission
- Device name
- Vulcan
- Applicant
- Cmp Industries, LLC
Albany, NY, US - Received
- July 31, 1995
- Decision date
- September 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Vulcan cleared by the FDA?
Vulcan (K953594) received a 510(k) decision of Substantially Equivalent on September 5, 1995, 36 days after the submission was received.
What is the product code of K953594?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.