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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 K093659
Device Name ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5
Applicant
C.R. BARD, INC.
1625 WEST 3RD ST.
P.O. BOX 1740
TEMPE,  AZ  85280 -1740
Applicant Contact Joni Creal
Correspondent
C.R. BARD, INC.
1625 WEST 3RD ST.
P.O. BOX 1740
TEMPE,  AZ  85280 -1740
Correspondent Contact Joni Creal
Regulation Number870.3375
Classification Product Code
DTK  
Date Received11/25/2009
Decision Date 01/14/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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