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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 K050104
Device Name APEX MEDICAL MININEB & MINIPLUS
Applicant
APEX MEDICAL CORP.
NO. 9, MINSHENG STREET
TUCHENG CITY, TAIPEI COUNTY,  TW 236
Applicant Contact ANAN CHANG
Correspondent
APEX MEDICAL CORP.
NO. 9, MINSHENG STREET
TUCHENG CITY, TAIPEI COUNTY,  TW 236
Correspondent Contact ANAN CHANG
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/18/2005
Decision Date 02/16/2005
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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