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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K974708
Device Name GEMINI STANDARD AND MINI VALVES
Applicant
NEUROCARE GROUP
8401 102ND STREET, SUITE 200
P.O. BOX 390
PLEASANT PRAIRIE,  WI  53158 -0390
Applicant Contact LORI L HAYS
Correspondent
NEUROCARE GROUP
8401 102ND STREET, SUITE 200
P.O. BOX 390
PLEASANT PRAIRIE,  WI  53158 -0390
Correspondent Contact LORI L HAYS
Regulation Number882.5550
Classification Product Code
JXG  
Date Received12/17/1997
Decision Date 03/10/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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