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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 K925781
Device Name DISPOSABLE CUFFED ENDOTRACHEAL TUBE
Applicant
COAST MEDICAL CORP.
1060 NORTH BATAVIA
UNIT H
ORANGE,  CA  92667
Applicant Contact DOUGLAS R MONGEON
Correspondent
COAST MEDICAL CORP.
1060 NORTH BATAVIA
UNIT H
ORANGE,  CA  92667
Correspondent Contact DOUGLAS R MONGEON
Regulation Number868.5730
Classification Product Code
BTR  
Date Received11/12/1992
Decision Date 04/19/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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