GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM


Device Classification Name

neurological stereotaxic instrument

510(k) Number K112469
Device Name GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM
Applicant
SONOWAND AS
435 rice creek terrance ne
fridley, 
MN 
55432

Applicant Contact constance g bundy
Correspondent
SONOWAND AS
435 rice creek terrance ne
fridley, 
MN 
55432

Correspodent Contact constance g bundy
Regulation Number 882.4560
Classification Product Code
HAW  
Subsequent Product Code
IYN  
Date Received 08/26/2011
Decision Date 03/23/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No