PMT Accessory Depthalon Electrode Anchor Bolt (2103-23-XX)
FDA 510(k) K970418 · Pmt Corp.
510(k) numberK970418
Submission
- Device name
- PMT Accessory Depthalon Electrode Anchor Bolt (2103-23-XX)
- Applicant
- Pmt Corp.
Chanhassen, MN, US - Received
- February 4, 1997
- Decision date
- April 29, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was PMT Accessory Depthalon Electrode Anchor Bolt (2103-23-XX) cleared by the FDA?
PMT Accessory Depthalon Electrode Anchor Bolt (2103-23-XX) (K970418) received a 510(k) decision of Substantially Equivalent on April 29, 1997, 84 days after the submission was received.
What is the product code of K970418?
The FDA product code is GZL – Electrode, Depth, a Class II (moderate risk) device regulated under 21 CFR 882.1330.