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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K940092
Device Name USCI INPUT INTRODUCER SET
Applicant
USCI, DIV. C.R. BARD, INC.
1200 TECHNOLOGY PARK DR.
P.O. BOX 7025
BILLERICA,  MA  01821
Applicant Contact JANET D BENSON
Correspondent
USCI, DIV. C.R. BARD, INC.
1200 TECHNOLOGY PARK DR.
P.O. BOX 7025
BILLERICA,  MA  01821
Correspondent Contact JANET D BENSON
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/07/1994
Decision Date 08/10/1995
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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