The following data is part of a premarket notification filed by Pmt Corporation with the FDA for Pmt Platinum Depthalon Depth Electrode.
Device ID | K151790 |
510k Number | K151790 |
Device Name: | PMT Platinum Depthalon Depth Electrode |
Classification | Electrode, Depth |
Applicant | PMT CORPORATION 1500 PARK RD Chanhassen, MN 55317 |
Contact | Kim Schmelzer |
Correspondent | Kim Schmelzer PMT CORPORATION 1500 PARK RD Chanhassen, MN 55317 |
Product Code | GZL |
CFR Regulation Number | 882.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-01 |
Decision Date | 2016-07-14 |