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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 K922105
Device Name USCI LINX EZ GUIDE WIRE EXTEN. W/ PRO/PEL COATING
Applicant
C.R. BARD, INC.
1200 TECHNOLOGY PARK DR.
P.O. BOX 7025
BILLERICA,  MA  01821
Applicant Contact CHRISTIE ERICKSON
Correspondent
C.R. BARD, INC.
1200 TECHNOLOGY PARK DR.
P.O. BOX 7025
BILLERICA,  MA  01821
Correspondent Contact CHRISTIE ERICKSON
Regulation Number870.1200
Classification Product Code
DQO  
Date Received05/06/1992
Decision Date 11/17/1992
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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