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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 K013025
Device Name MODIFICATION TO FLOUROLAB PLUS
Applicant
Z-KAT, INC.
2903 SIMMS ST.
HOLLYWOOD,  FL  33020
Applicant Contact WILLIAM F TAPIA
Correspondent
Z-KAT, INC.
2903 SIMMS ST.
HOLLYWOOD,  FL  33020
Correspondent Contact WILLIAM F TAPIA
Regulation Number882.4560
Classification Product Code
HAW  
Date Received09/10/2001
Decision Date 10/03/2001
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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