BRAIN BIOPSY NEEDLE


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

Correspodent Contact gary j syring
Regulation Number 882.4560
Classification Product Code
HAW  
Subsequent Product Code
FCG  
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