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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 K083763
FOIA Releasable 510(k) K083763
Device Name ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN
Applicant
R4 Vascular, Inc.
7550 Meridian Cir. N
Maple Grove,  MN  55369
Applicant Contact LAURIE LEWANDOWSKI
Correspondent
R4 Vascular, Inc.
7550 Meridian Cir. N
Maple Grove,  MN  55369
Correspondent Contact LAURIE LEWANDOWSKI
Regulation Number880.5970
Classification Product Code
LJS  
Date Received12/18/2008
Decision Date 03/16/2009
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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