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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
510(k) Number K851466
Device Name CARNATION - OXYGEN MASK
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 Number868.5580
Classification Product Code
BYG  
Date Received04/11/1985
Decision Date 06/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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