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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 K061479
Device Name ARGOS
Applicant
3D LINE MEDICAL SYSTEMS S.R.L.
VIA BERNARDO RUCELLAI 23
MILAN,  IT 20161
Applicant Contact MARCO LUZZARA
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number882.4560
Classification Product Code
HAW  
Date Received05/30/2006
Decision Date 04/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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