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FDA 510(k) Application Details - K211593
Device Classification Name
More FDA Info for this Device
510(K) Number
K211593
Device Name
Enteral Pump Syringe
Applicant
Jiangsu Caina Medical Co., Ltd.
No.23, Huanxi Road, Zhutang Town
Jiangyin 214415 CN
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Contact
Jianwei Pan
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Regulation Number
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Classification Product Code
PNR
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More FDA Info for this Product Code
Date Received
05/24/2021
Decision Date
09/30/2021
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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