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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Oxygen, Low Concentration, Venturi
510(k) Number K894457
Device Name CARNATION TRACHEOSTOMY MASKS
Applicant
DADSUN CORP., LTD.
P.O. BOX 73-30
TAIPEI,  TW
Applicant Contact HENRY CHEN
Correspondent
DADSUN CORP., LTD.
P.O. BOX 73-30
TAIPEI,  TW
Correspondent Contact HENRY CHEN
Regulation Number868.5600
Classification Product Code
BYF  
Date Received07/18/1989
Decision Date 10/13/1989
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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