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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
Predetermined Change
Control Plan Authorized		 No
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