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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(k) Number K110134
Device Name NC TREK RX CORONARY DILATATION CATHETER
Applicant
ABBOTT VASCULAR-CARDIAC THERAPIES
26531 YNEZ RD.
MAILING P.O. BOX 9018
TEMECULA,  CA  92589 -9018
Applicant Contact SUZANNE REDMAN
Correspondent
ABBOTT VASCULAR-CARDIAC THERAPIES
26531 YNEZ RD.
MAILING P.O. BOX 9018
TEMECULA,  CA  92589 -9018
Correspondent Contact SUZANNE REDMAN
Regulation Number870.5100
Classification Product Code
LOX  
Date Received01/18/2011
Decision Date 02/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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