K-number	K242582
Device name	Optima Coil System (OptiBlock Line Extension)
Applicant	Balt USA, LLC
Product code	HCG
Device class	Class II
Decision date	Sep 27, 2024
Decision	Substantially Equivalent
Regulation	882.5950

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View the full FDA submission: accessdata.fda.gov

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Optima Coil System (OptiBlock Line Extension)

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