Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K112094 |
Device Name |
BRAIN BIOPSY NEEDLE |
Applicant |
AD-TECH MEDICAL INSTRUMENT CORP. |
800 LEVANGER LANE |
STOUGHTON,
WI
53589
|
|
Applicant Contact |
Gary J Syring |
Correspondent |
AD-TECH MEDICAL INSTRUMENT CORP. |
800 LEVANGER LANE |
STOUGHTON,
WI
53589
|
|
Correspondent Contact |
Gary J Syring |
Regulation Number | 882.4560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/22/2011 |
Decision Date | 04/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|