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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
510(k) Number K192684
Device Name HydroPearl Microspheres
Applicant
MicroVention, Inc.
35 Enterprise
Aliso Viejo,  CA  92656
Applicant Contact Analia Staubly
Correspondent
MicroVention, Inc.
35 Enterprise
Aliso Viejo,  CA  92656
Correspondent Contact Analia Staubly
Regulation Number876.5550
Classification Product Code
NOY  
Subsequent Product Codes
KRD   NAJ  
Date Received09/26/2019
Decision Date 01/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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