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FDA 510(k) Application Details - K990435
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K990435
Device Name
Nebulizer (Direct Patient Interface)
Applicant
APEX MEDICAL CORP.
10TH FLOOR, NO.31, LANE 169
KANG NING STREET
HSI-CHIH CITY, TAIPEI HSIEN TW
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Contact
DANIEL LEE
Other 510(k) Applications for this Contact
Regulation Number
868.5630
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Classification Product Code
CAF
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More FDA Info for this Product Code
Date Received
02/11/1999
Decision Date
06/05/2000
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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