Name: Predicase
Price: 199 USD

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
Product code	PJN
Device class	Class II
Decision date	Oct 10, 2019
Decision	Substantially Equivalent
Regulation	882.5330

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Source

View the full FDA submission: accessdata.fda.gov

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Cranial PSI Accessory  Anatomical Model Original, Cranial PSI Accessory  Anatomical Model Modified, Cranial PSI Accessory  Plastic Drawing Guide, Cranial PSI Accessory  Cranial Implant Trial

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Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory Anatomical Model Modified, Cranial PSI Accessory Plastic Drawing Guide, Cranial PSI Accessory Cranial Implant Trial