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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K083657
Device Name CONQUEST PTA BALLOON DILATATION CATHETER
Applicant
C.R. BARD, INC.
1625 WEST 3RD ST.
TEMPE,  AZ  85281 -1740
Applicant Contact GENEVIEVE BALUTOWSKI
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/10/2008
Decision Date 12/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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