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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name filler, bone void, non-alterable compound for cranioplasty
510(k) Number K190523
Device Name Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial
Applicant
OssDsign AB
Virdings Alle 2
Uppsala,  SE SE 754 50
Applicant Contact Ulrik Birgersson
Correspondent
Weissburg Associates
300 2nd Avenue SE, #14
St. Petersburg,  FL  33701
Correspondent Contact David Weissburg
Regulation Number882.5330
Classification Product Code
PJN  
Date Received03/04/2019
Decision Date 10/10/2019
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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