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FDA 510(k) Application Details - K140237
Device Classification Name
Nebulizer (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K140237
Device Name
Nebulizer (Direct Patient Interface)
Applicant
SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD
7TH FL. JINGUI BUSINESS BUIDLING NO. 982
CONGYUN RD, BAIYUN DISTRICT
GUANGZHOU, GUANGDONG 510420 CN
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Contact
MIKE GU
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
01/30/2014
Decision Date
01/08/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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