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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 K102511
Device Name MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT
Applicant
C.R. BARD, INC.
1625 WEST 3RD ST.
TEMPE,  AZ  85281 -1740
Applicant Contact Joni Creal
Correspondent
C.R. BARD, INC.
1625 WEST 3RD ST.
TEMPE,  AZ  85281 -1740
Correspondent Contact Joni Creal
Regulation Number870.3375
Classification Product Code
DTK  
Date Received09/01/2010
Decision Date 08/24/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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