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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K141981
Device Name ASAHI FUBUKI 043 / ASAHI FUBUKI
Applicant
Asahi Intecc Co., Ltd.
5523 Research Park Dr., Suite 205
Baltimore,  MD  21228
Applicant Contact CANDACE CEDERMAN
Correspondent
Asahi Intecc Co., Ltd.
5523 Research Park Dr., Suite 205
Baltimore,  MD  21228
Correspondent Contact CANDACE CEDERMAN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received07/21/2014
Decision Date 03/09/2015
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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