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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 K083920
Device Name FLOWPICC CATHETER
Applicant
Vasonova, Inc.
1368 Bordeaux Dr., Suite 100
Sunnyvale,  CA  94089
Applicant Contact KIM TOMPKINS
Correspondent
Vasonova, Inc.
1368 Bordeaux Dr., Suite 100
Sunnyvale,  CA  94089
Correspondent Contact KIM TOMPKINS
Regulation Number880.5970
Classification Product Code
LJS  
Date Received12/31/2008
Decision Date 05/01/2009
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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