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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Burr Hole
510(k) Number K160739
Device Name Cranial COVER
Applicant
Neos Surgery S.L
Parc Tecnologic Del Valles, C/Ceramistes, 2
Cerdanyola Del Valles,  ES 08290
Applicant Contact Eduard Garcia
Correspondent
Msquared Associates, Inc.
575 Eighth Ave.
Suite 1212
New York,  NY  10018
Correspondent Contact Marcos Velez-Duran
Regulation Number882.5250
Classification Product Code
GXR  
Date Received03/17/2016
Decision Date 06/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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