The following data is part of a premarket notification filed by Fhc, Inc. with the FDA for Microtargeting Guideline 4000.
| Device ID | K071364 |
| 510k Number | K071364 |
| Device Name: | MICROTARGETING GUIDELINE 4000 |
| Classification | Electrode, Depth |
| Applicant | FHC, INC. 1201 MAIN ST Bowdoin, ME 04287 |
| Contact | Lee D Margolin |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-05-16 |
| Decision Date | 2007-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00873263006108 | K071364 | 000 |
| 00873263001394 | K071364 | 000 |
| 00873263001516 | K071364 | 000 |
| 00873263001554 | K071364 | 000 |
| 00873263002575 | K071364 | 000 |
| 00873263002582 | K071364 | 000 |
| 00873263002650 | K071364 | 000 |
| 00873263002698 | K071364 | 000 |
| 00873263002711 | K071364 | 000 |
| 00873263002797 | K071364 | 000 |
| 00873263002810 | K071364 | 000 |
| 00873263002858 | K071364 | 000 |
| 00873263005569 | K071364 | 000 |
| 00873263006085 | K071364 | 000 |
| 00873263008645 | K071364 | 000 |