The following data is part of a premarket notification filed by Fhc, Inc. with the FDA for Micro Targeting Drive System.
Device ID | K011775 |
510k Number | K011775 |
Device Name: | MICRO TARGETING 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-06-07 |
Decision Date | 2001-08-30 |
Summary: | summary |