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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tracheal (w/wo connector)
510(k) Number K091761
Device Name TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT
Applicant
Teleflex Medical, Inc.
2917 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Applicant Contact WILLIAM HEARD
Correspondent
Teleflex Medical, Inc.
2917 WECK DR.
RESEARCH TRIANGLE PARK,  NC  27709
Correspondent Contact WILLIAM HEARD
Regulation Number868.5730
Classification Product Code
BTR  
Date Received06/16/2009
Decision Date 10/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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