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FDA 510(k) Application Details - K202108
Device Classification Name
Device, Counter-Pulsating, External
More FDA Info for this Device
510(K) Number
K202108
Device Name
Device, Counter-Pulsating, External
Applicant
Vamed Medical Instrument Co., Ltd.
1 of 8 Floor, 2# Building, No. 60, Langbao West Road,
Chancheng District
Foshan 413200 CN
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Contact
Ji Ma
Other 510(k) Applications for this Contact
Regulation Number
870.5225
More FDA Info for this Regulation Number
Classification Product Code
DRN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/30/2020
Decision Date
08/28/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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