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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
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