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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer (direct patient interface)
510(k) Number K070990
Device Name APEX MEDICAL MOBINEB, 9R-027 SERIES
Applicant
APEX MEDICAL CORP.
NO. 9, MINSHENG ST.,
TU-CHENG
TAIPEI COUNTY,  TW 236
Applicant Contact ALAN CHANG
Correspondent
APEX MEDICAL CORP.
NO. 9, MINSHENG ST.,
TU-CHENG
TAIPEI COUNTY,  TW 236
Correspondent Contact ALAN CHANG
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/09/2007
Decision Date 05/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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