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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 K980631
Device Name EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULA
Applicant
Embol-X, Inc.
645 Clyde Ave.
Mountain View,  CA  94043
Applicant Contact JEAN CHANG
Correspondent
Embol-X, Inc.
645 Clyde Ave.
Mountain View,  CA  94043
Correspondent Contact JEAN CHANG
Regulation Number870.4450
Classification Product Code
DXC  
Date Received02/18/1998
Decision Date 02/02/1999
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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