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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K182538
Device Name Merit RadialFlo Arterial Catheter
Applicant
Merit Medical Singapore Pte. , Ltd.
198 Yishun Ave. 7
Singapore,  SG 768926
Applicant Contact Xing Ting Seow
Correspondent
Merit Medical Singapore Pte. , Ltd.
198 Yishun Ave. 7
Singapore,  SG 768926
Correspondent Contact Xing Ting Seow
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/14/2018
Decision Date 01/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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