Name: Predicase
Price: 199 USD

K-number	K220040
Device name	CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
Applicant	Medos International SARL
Product code	HCG
Device class	Class II
Decision date	Jul 14, 2022
Decision	Substantially Equivalent
Regulation	882.5950

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Source

View the full FDA submission: accessdata.fda.gov

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CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems

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