The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Stainless Steel Cortac Cortical Electrode(2111)/plantinum Cortac Cortical Electrode.
| Device ID | K964224 |
| 510k Number | K964224 |
| Device Name: | STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE |
| Classification | Electrode, Cortical |
| Applicant | PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
| Contact | Edward F Valdez |
| Correspondent | Edward F Valdez 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 | 1996-10-23 |
| Decision Date | 1997-03-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00650551002192 | K964224 | 000 |
| 00650551002185 | K964224 | 000 |
| 00650551002215 | K964224 | 000 |
| 00650551002369 | K964224 | 000 |
| 00650551002352 | K964224 | 000 |
| 00650551002338 | K964224 | 000 |
| 00650551002321 | K964224 | 000 |