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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 K112554
Device Name TRANSRADIAL ARTERY ACCESS DEVICES
Applicant
Teleflexmedical, Inc.
2400 Bernville Rd.
Reading,  PA  19605
Applicant Contact CHRISTINE FORD
Correspondent
Teleflexmedical, Inc.
2400 Bernville Rd.
Reading,  PA  19605
Correspondent Contact CHRISTINE FORD
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/02/2011
Decision Date 11/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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