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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 K181539
Device Name OSSDSIGN Cranioplug
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 Number882.5250
Classification Product Code
GXR  
Date Received06/11/2018
Decision Date 10/12/2018
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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