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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 K080105
Device Name ENDOTRACHEAL TUBE
Applicant
CHILECOM MEDICAL DEVICES CO., LTD.
155 FLEMINGTON CT.
LA MIRADA,  CA  90638
Applicant Contact BRANDON CHOI
Correspondent
CHILECOM MEDICAL DEVICES CO., LTD.
155 FLEMINGTON CT.
LA MIRADA,  CA  90638
Correspondent Contact BRANDON CHOI
Regulation Number868.5730
Classification Product Code
BTR  
Date Received01/14/2008
Decision Date 02/13/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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