K-number	K220420
Device name	Saffron Fixation System
Applicant	Coloplast A/S
Product code	PBQ
Device class	Class II
Decision date	Jun 10, 2022
Decision	Substantially Equivalent
Regulation	884.4530

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Source

View the full FDA submission: accessdata.fda.gov

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Saffron Fixation System

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