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 Other 510(k) Applications for this Company
Contact	Ulrik Birgersson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
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