Device Classification Name |
electrode, depth
|
510(k) Number |
K181544 |
Device Name |
Anchor Bolt (as an accessory to Depth Electrodes) |
Applicant |
Ad-Tech Medical Instrument Corporation |
400 West Oakwood Road |
Oak Creek,
WI
53154
|
|
Applicant Contact |
Lisa Theama |
Correspondent |
Quality & Regulatory Associates, LLC |
800 Levanger Lane |
Stoughton,
WI
53589
|
|
Correspondent Contact |
Gary Syring |
Regulation Number | 882.1330
|
Classification Product Code |
|
Date Received | 06/12/2018 |
Decision Date | 08/09/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|