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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 K082520
Device Name SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
Applicant
MALLINCKRODT MEDICAL
6135 GUNBARREL AVE.
BOULDER,  CO  80301
Applicant Contact SCOTT D DICKERHOFF
Correspondent
MALLINCKRODT MEDICAL
6135 GUNBARREL AVE.
BOULDER,  CO  80301
Correspondent Contact SCOTT D DICKERHOFF
Regulation Number868.5730
Classification Product Code
BTR  
Date Received09/02/2008
Decision Date 10/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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