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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Intravascular, Cardiovascular
510(k) Number K082305
Device Name G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
Applicant
C.R. Bard, Inc.
1625 W. 3rd St.
P.O. Box 1740
Tempe,  AZ  85280
Applicant Contact GENEVIEVE BALUTOWSKI
Correspondent
C.R. Bard, Inc.
1625 W. 3rd St.
P.O. Box 1740
Tempe,  AZ  85280
Correspondent Contact GENEVIEVE BALUTOWSKI
Regulation Number870.3375
Classification Product Code
DTK  
Date Received08/13/2008
Decision Date 10/31/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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