Hemostatic Xerogel Sponge

Dressing, Wound, Drug

Solaplus Biotech Co., Ltd.

The following data is part of a premarket notification filed by Solaplus Biotech Co., Ltd. with the FDA for Hemostatic Xerogel Sponge.

Pre-market Notification Details

Device IDK192671
510k NumberK192671
Device Name:Hemostatic Xerogel Sponge
ClassificationDressing, Wound, Drug
Applicant Solaplus Biotech Co., Ltd. No. 75 Feng Fang Road, Ouhai Economic Development Zone Wenzhou,  CN 325014
ContactXiangui Shen
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai Shanghai,  CN 200120
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-26
Decision Date2020-08-28

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