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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clamp, vascular
510(k) Number K131411
Device Name COSEAL
Applicant
JILIN CORONADO MEDICAL LTD.
9 South-Western Circle Road
Fenman Econormic Development Zone
Jilin,  CN 132016
Applicant Contact ERIC CHIEN
Correspondent
JILIN CORONADO MEDICAL LTD.
9 South-Western Circle Road
Fenman Econormic Development Zone
Jilin,  CN 132016
Correspondent Contact ERIC CHIEN
Regulation Number870.4450
Classification Product Code
DXC  
Date Received05/15/2013
Decision Date 09/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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