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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 K953039
Device Name VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS
Applicant
DADSUN CORP., LTD.
P.O. BOX 73-30
TAIPEI,  TW
Applicant Contact JIMMY WANG
Correspondent
DADSUN CORP., LTD.
P.O. BOX 73-30
TAIPEI,  TW
Correspondent Contact JIMMY WANG
Regulation Number868.5580
Classification Product Code
BYG  
Date Received06/13/1995
Decision Date 09/15/1995
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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