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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name neurological stereotaxic instrument
510(k) Number K023975
Device Name VOYAGER LINUX
Applicant
Z-KAT, INC.
2903 SIMMS ST.
HOLLYWOOD,  FL  33020
Applicant Contact CHRISTINA VANCE
Correspondent
Z-KAT, INC.
2903 SIMMS ST.
HOLLYWOOD,  FL  33020
Correspondent Contact CHRISTINA VANCE
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/02/2002
Decision Date 12/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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