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FDA 510(k) Application Details - K170027
Device Classification Name
Syringe, Balloon Inflation
More FDA Info for this Device
510(K) Number
K170027
Device Name
Syringe, Balloon Inflation
Applicant
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
NO. 925 JINYUAN YI RD
SHANGHAI 201803 CN
Other 510(k) Applications for this Company
Contact
Xu Jianhai
Other 510(k) Applications for this Contact
Regulation Number
870.1650
More FDA Info for this Regulation Number
Classification Product Code
MAV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/03/2017
Decision Date
10/06/2017
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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