SilverStream Gel

Dressing, Wound, Drug

EnzySurge Ltd.

The following data is part of a premarket notification filed by Enzysurge Ltd. with the FDA for Silverstream Gel.

Pre-market Notification Details

Device IDK200767
510k NumberK200767
Device Name:SilverStream Gel
ClassificationDressing, Wound, Drug
Applicant EnzySurge Ltd. 26 Shabazi St. Rosh Ha'ayin,  IL 4802126
ContactMoshe Landsberg
CorrespondentDaniel Albahari
BioReg Services 6 Beit HaShoeva St. Jerusalem,  IL 9751723
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2020-03-25
Decision Date2020-10-08

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