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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K932092
Device Name USCI ANGIOGRAPHIC CATHETER
Applicant
C.R Bard, Inc.
1200 Technology Park Dr.
P.O. Box 7025
Billerica,  MA  01821
Applicant Contact BETH ROCHETTE
Correspondent
C.R Bard, Inc.
1200 Technology Park Dr.
P.O. Box 7025
Billerica,  MA  01821
Correspondent Contact BETH ROCHETTE
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/30/1993
Decision Date 07/29/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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