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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 K112497
Device Name MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT
Applicant
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281 -1740
Applicant Contact Joni Creal
Correspondent
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281 -1740
Correspondent Contact Joni Creal
Regulation Number870.3375
Classification Product Code
DTK  
Date Received08/29/2011
Decision Date 10/24/2011
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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