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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K925058
Device Name BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET
Applicant
C.R. Bard, Inc.
87 Concord Rd.
North Reading,  MA  01864
Applicant Contact BRUCE W HUSEL
Correspondent
C.R. Bard, Inc.
87 Concord Rd.
North Reading,  MA  01864
Correspondent Contact BRUCE W HUSEL
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/06/1992
Decision Date 08/03/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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