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FDA 510(k) Application Details - K150591
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K150591
Device Name
Nebulizer (Direct Patient Interface)
Applicant
BESMED HEALTH BUSINESS CORP.
NO.5, LANE116, WU-KONG 2ND RD
NEW TAIPEI CITY 24888 TW
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Contact
WINNIE CHUNG
Other 510(k) Applications for this Contact
Regulation Number
868.5630
More FDA Info for this Regulation Number
Classification Product Code
CAF
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More FDA Info for this Product Code
Date Received
03/09/2015
Decision Date
06/30/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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