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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 K212414
Device Name OSSDSIGN Cranial PSI
OssDsign AB
Rapsgatan 23A
Uppsala,  SE SE 754 50
Applicant Contact Ulrik Birgersson
David Weissburg
411 Walnut Street #16642
Green Cove Springs,  FL  32043 -3443
Correspondent Contact David Weissburg
Regulation Number882.5330
Classification Product Code
Date Received08/03/2021
Decision Date 10/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No