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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K030467
Device Name GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLLER EXTENSION SET
Applicant
Iv Medical, Inc.
7854 Sitio Coco
Carlsbad,  CA  92009
Applicant Contact MICHAEL G SIMON
Correspondent
Iv Medical, Inc.
7854 Sitio Coco
Carlsbad,  CA  92009
Correspondent Contact MICHAEL G SIMON
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/12/2003
Decision Date 03/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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