K-number	K203183
Device name	CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
Applicant	Bolder Surgical, LLC
Product code	GEI
Device class	Class II
Decision date	May 6, 2021
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)

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