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510(k) K173871

CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres by Suzhou Hengrui Callisyn Biomedical Co., Ltd. — Product Code NAJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2018
Date Received
December 20, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agents, Embolic, For Treatment Of Uterine Fibroids
Device Class
Class II
Regulation Number
870.3300
Review Panel
OB
Submission Type

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  • K021397 — EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMB (November 22, 2002)