K-number	K212414
Device name	OSSDSIGN Cranial PSI
Applicant	Ossdsign AB
Product code	PJN
Device class	Class II
Decision date	Oct 1, 2021
Decision	Substantially Equivalent
Regulation	882.5330

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Source

View the full FDA submission: accessdata.fda.gov

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OSSDSIGN Cranial PSI

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