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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Non-Alterable
510(k) Number K161090
FOIA Releasable 510(k) K161090
Device Name Cranial PSI
Applicant
Ossdsign AB
Virdings Alle 2
Uppsala,  SE SE 754 50
Applicant Contact ULRIK BIRGERSSON
Correspondent
Weissburg Associates
808 Williamson St., Suite 402
Madison,  WI  53703
Correspondent Contact DAVID WEISSBURG
Regulation Number882.5330
Classification Product Code
GXN  
Date Received04/18/2016
Decision Date 01/19/2017
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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