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FDA 510(k) Application Details - K192671
Device Classification Name
More FDA Info for this Device
510(K) Number
K192671
Device Name
Hemostatic Xerogel Sponge
Applicant
Solaplus Biotech Co., Ltd.
No. 75 Feng Fang Road, Ouhai Economic Development Zone
Wenzhou 325014 CN
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Contact
Xiangui Shen
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QSY
Other 510(k) Applications for this Device
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Date Received
09/26/2019
Decision Date
08/28/2020
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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