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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 K884104
Device Name USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR
Applicant
C.R. BARD, INC.
ONE PARK WEST
TEWKSBURY,  MA  01876 -1234
Applicant Contact JOSEPH CURTIS
Correspondent
C.R. BARD, INC.
ONE PARK WEST
TEWKSBURY,  MA  01876 -1234
Correspondent Contact JOSEPH CURTIS
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/29/1988
Decision Date 12/21/1988
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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