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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 K050558
Device Name MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F
Applicant
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281 -1740
Applicant Contact KAREN HUTCHISON
Correspondent
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281 -1740
Correspondent Contact KAREN HUTCHISON
Regulation Number870.3375
Classification Product Code
DTK  
Date Received03/03/2005
Decision Date 08/29/2005
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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