The following data is part of a premarket notification filed by Fhc, Inc. with the FDA for Fhc Microtargeting Drive System.
| Device ID | K011992 |
| 510k Number | K011992 |
| Device Name: | FHC MICROTARGETING DRIVE SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| 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 | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-26 |
| Decision Date | 2001-08-14 |
| Summary: | summary |