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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 K850626
Device Name CARNATION OXYGEN
Applicant
CATHAY CONSOLIDATED, INC.
P.O. BOX 333
TAIPEI,  TW
Applicant Contact MARY VALENTINE
Correspondent
CATHAY CONSOLIDATED, INC.
P.O. BOX 333
TAIPEI,  TW
Correspondent Contact MARY VALENTINE
Regulation Number868.5580
Classification Product Code
BYG  
Date Received02/19/1985
Decision Date 03/12/1985
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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