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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stripper, artery, intraluminal
510(k) Number K032105
Device Name ENDOHELIX ENDARTERECTOMY DEVICE
Applicant
ENDARX, INC.
3270 ALPINE ROAD
PORTOLA VALLEY,  CA  94028
Applicant Contact SCOTT ADAMS
Correspondent
ENDARX, INC.
3270 ALPINE ROAD
PORTOLA VALLEY,  CA  94028
Correspondent Contact SCOTT ADAMS
Regulation Number870.4875
Classification Product Code
DWX  
Date Received07/08/2003
Decision Date 10/30/2003
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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