Name: Predicase
Price: 199 USD

K-number	K173871
Device name	CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
Applicant	Suzhou Hengrui Callisyn Biomedical Co., Ltd.
Product code	NAJ
Device class	Class II
Decision date	Sep 17, 2018
Decision	Substantially Equivalent
Regulation	870.3300

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Source

View the full FDA submission: accessdata.fda.gov

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CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres

Everything you need for a 510(k) submission. Nothing you don't.