The following data is part of a premarket notification filed by Progress Mankind Technology with the FDA for Pmt Depthalon Depth Corticography Elec.
Device ID | K802151 |
510k Number | K802151 |
Device Name: | PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC |
Classification | Electrode, Depth |
Applicant | PROGRESS MANKIND TECHNOLOGY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GZL |
CFR Regulation Number | 882.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-08 |
Decision Date | 1980-11-19 |