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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 uterine fibroids
510(k) Number K130259
Device Name BEARING NSPVA EMBOLIZATION PARTICLES
Applicant
MERIT MEDICAL SYSTEMS, INC.
1050 HINGHAM ST
ROCKLAND,  MA  02370
Applicant Contact LINDA VARROSO
Correspondent
MERIT MEDICAL SYSTEMS, INC.
1050 HINGHAM ST
ROCKLAND,  MA  02370
Correspondent Contact LINDA VARROSO
Regulation Number870.3300
Classification Product Code
NAJ  
Subsequent Product Code
KRD  
Date Received02/01/2013
Decision Date 06/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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