K-number	K211577
Device name	SoftFix Balloon Trocar
Applicant	Unimax Medical Systems, Inc.
Product code	GCJ
Device class	Class II
Decision date	Nov 5, 2021
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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SoftFix Balloon Trocar

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