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FDA 510(k) Application Details - K201324
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K201324
Device Name
Dressing, Wound, Drug
Applicant
Jiangsu Excellence Medical Supplies Co., Ltd
No.65 Huiling West Road, Zouqu Town, Zhonglou District
Changzhou 203144 CN
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Contact
Yanhua Li
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/18/2020
Decision Date
02/05/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
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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