The following data is part of a premarket notification filed by Fhc, Inc. with the FDA for Microtargeting Electrode.
| Device ID | K991522 |
| 510k Number | K991522 |
| Device Name: | MICROTARGETING ELECTRODE |
| Classification | Electrode, Depth |
| Applicant | FHC, INC. 9 MAIN ST. Bowdoinham, ME 04008 |
| Contact | Frederick Haer |
| Correspondent | Frederick Haer FHC, INC. 9 MAIN ST. Bowdoinham, ME 04008 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-03 |
| Decision Date | 2000-08-04 |
| Summary: | summary |