SPHERZ


Device Classification Name

neurological stereotaxic instrument

510(k) Number K022074
Device Name SPHERZ
Original Applicant
I.Z.I. CORP.
7020 tudsbury rd.
baltimore, 
MD 
21244

Original Contact helen zinreich
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 06/26/2002
Decision Date 08/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls