The following data is part of a premarket notification filed by Fhc, Inc. with the FDA for Micro Targeting Electrode.
Device ID | K033173 |
510k Number | K033173 |
Device Name: | MICRO TARGETING 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 | 2003-10-01 |
Decision Date | 2004-03-24 |
Summary: | summary |