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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 K161402
Device Name Bullfrog Micro-Infusion Device
Applicant
Mercator Medsystems, Inc.
1900 Powell St.
Suite 800
Emeryville,  CA  94608
Applicant Contact Kirk P. Seward
Correspondent
Target Health, Inc.
261 Madison Ave., 24th Floor
New York,  NY  10016
Correspondent Contact Adam Harris
Regulation Number870.1210
Classification Product Code
KRA  
Date Received05/20/2016
Decision Date 08/18/2016
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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