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FDA 510(k) Application Details - K172989
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K172989
Device Name
Pump, Breast, Powered
Applicant
Joytech Healthcare Co., Ltd.
No.365, Wuzhou Road, Yuhang Economic Development Zone
Hangzhou City
Hangzhou 311100 CN
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Contact
Ren Yunhua
Other 510(k) Applications for this Contact
Regulation Number
884.5160
More FDA Info for this Regulation Number
Classification Product Code
HGX
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More FDA Info for this Product Code
Date Received
09/27/2017
Decision Date
12/20/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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