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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K153501
Device Name Bullfrog Micro-Infusion Device
Applicant
MERCATOR MEDSYSTEMS, INC.
2200 POWELL STREET
SUITE 530
EMERYVILLE,  CA  94608
Applicant Contact KIRK P. SEWARD
Correspondent
TARGET HEALTH, INC.
261 MADISON AVENUE
24TH FLOOR
NEW YORK,  NY  10016
Correspondent Contact ADAM HARRIS
Regulation Number870.1210
Classification Product Code
KRA  
Date Received12/07/2015
Decision Date 04/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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