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FDA 510(k) Application Details - K202898
Device Classification Name
Negative Pressure Wound Therapy Powered Suction Pump
More FDA Info for this Device
510(K) Number
K202898
Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Applicant
Lightstone Medical Products (Ningbo) Co Ltd
Room 61-408, No. 99 Jiangbei Road
Ningbo 315032 CN
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Contact
Julian Zhu
Other 510(k) Applications for this Contact
Regulation Number
878.4780
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Classification Product Code
OMP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2020
Decision Date
12/30/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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