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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K093775
FOIA Releasable 510(k) K093775
Device Name EVGUIDE TIP LOCATION SYSTEM
Applicant
ROMEDEX INTERNATIONAL SRL
175 COLORADO AVENUE
PALO ALTO,  CA  94303
Applicant Contact SORIN GRUNWALD
Correspondent
ROMEDEX INTERNATIONAL SRL
175 COLORADO AVENUE
PALO ALTO,  CA  94303
Correspondent Contact SORIN GRUNWALD
Regulation Number880.5970
Classification Product Code
LJS  
Date Received12/08/2009
Decision Date 07/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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