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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K060980
Device Name VENDYS MODEL 5000 B/BC
Applicant
ENDOTHELIX, INC.
2472 BOLSOVER
SUITE 439C
HOUSTON,  TX  77005
Applicant Contact DOUGLAS BLAKELY
Correspondent
ENDOTHELIX, INC.
2472 BOLSOVER
SUITE 439C
HOUSTON,  TX  77005
Correspondent Contact DOUGLAS BLAKELY
Regulation Number870.1425
Classification Product Code
DQK  
Date Received04/10/2006
Decision Date 08/16/2007
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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