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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
510(k) Number K884200
Device Name USCI TANDEM ADAPTER
Applicant
C.R. BARD, INC.
1200 TECHNOLOGY PARK DR.
P.O. BOX 7025
BILLERICA,  MA  01821
Applicant Contact JANICE PIASECKI
Correspondent
C.R. BARD, INC.
1200 TECHNOLOGY PARK DR.
P.O. BOX 7025
BILLERICA,  MA  01821
Correspondent Contact JANICE PIASECKI
Regulation Number870.4290
Classification Product Code
DTL  
Date Received10/06/1988
Decision Date 12/05/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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