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FDA 510(k) Application Details - K171889
Device Classification Name
Blood Pressure Cuff
More FDA Info for this Device
510(K) Number
K171889
Device Name
Blood Pressure Cuff
Applicant
Suzhou Minhua Medical Apparatus Supplies Co., LTD
You Yi Industrial Park, Songlin Town, Wujiang
Suzhou 215222 CN
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Contact
Yang Qidong
Other 510(k) Applications for this Contact
Regulation Number
870.1120
More FDA Info for this Regulation Number
Classification Product Code
DXQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/26/2017
Decision Date
12/19/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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