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FDA 510(k) Application Details - K192179
Device Classification Name
More FDA Info for this Device
510(K) Number
K192179
Device Name
Oral/Enteral Syringe
Applicant
Shanghai Kindly Enterprise Development Group Co., Ltd
No. 658 Gaochao Road
Shanghai 201803 CN
Other 510(k) Applications for this Company
Contact
Weixin Zhang
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PNR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/12/2019
Decision Date
05/01/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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