PRAEZIS PLUS


Device Classification Name

neurological stereotaxic instrument

510(k) Number K110644
Device Name PRAEZIS PLUS
Applicant
TATRAMED SPOL. S.R.O.
611 w 5th st. 3rd floor
austin, 
TX 
78701

Applicant Contact caroline tontini
Correspondent
TATRAMED SPOL. S.R.O.
611 w 5th st. 3rd floor
austin, 
TX 
78701

Correspodent Contact caroline tontini
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 03/07/2011
Decision Date 05/24/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No