The following data is part of a premarket notification filed by Progress Mankind Technology with the FDA for Electrode For Neurological Surgery 2111.
Device ID | K845035 |
510k Number | K845035 |
Device Name: | ELECTRODE FOR NEUROLOGICAL SURGERY 2111 |
Classification | Electrode, Cortical |
Applicant | PROGRESS MANKIND TECHNOLOGY BOX 464 Hopkins, MN 55343 |
Contact | Alfred A Iversen |
Correspondent | Alfred A Iversen PROGRESS MANKIND TECHNOLOGY BOX 464 Hopkins, MN 55343 |
Product Code | GYC |
CFR Regulation Number | 882.1310 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-27 |
Decision Date | 1985-07-30 |