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FDA 510(k) Application Details - K190523
Device Classification Name
More FDA Info for this Device
510(K) Number
K190523
Device Name
Cranial PSI Accessory û Anatomical Model Original, Cranial PSI Accessory û Anatomical Model Modified, Cranial PSI Accessory û Plastic Drawing Guide, Cranial PSI Accessory û Cranial Implant Trial
Applicant
OssDsign AB
Virdings Alle 2
Uppsala SE 754 50 SE
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Contact
Ulrik Birgersson
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PJN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/04/2019
Decision Date
10/10/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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