510(k) K970418
K970418 is an FDA 510(k) premarket notification submitted by Pmt Corp. for the device "PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)". The FDA issued a decision of Substantially Equivalent on April 29, 1997. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Pmt Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 1997
- Date Received
- February 4, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Depth
- Device Class
- Class II
- Regulation Number
- 882.1330
- Review Panel
- NE
- Submission Type