The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Pmt Subdural Cortical Electrodes.
Device ID | K082474 |
510k Number | K082474 |
Device Name: | PMT SUBDURAL CORTICAL ELECTRODES |
Classification | Electrode, Cortical |
Applicant | PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
Contact | Eric Caille |
Correspondent | Eric Caille PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
Product Code | GYC |
CFR Regulation Number | 882.1310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-08-28 |
Decision Date | 2009-05-08 |
Summary: | summary |