K-number	K170871
Device name	DigniCap Scalp Cooling System
Applicant	Dignitana AB
Product code	PMC
Device class	Class II
Decision date	Jul 3, 2017
Decision	Substantially Equivalent
Regulation	878.4360

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Source

View the full FDA submission: accessdata.fda.gov

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DigniCap Scalp Cooling System

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