KeraStat Cream

Dressing, Wound, Collagen

KeraNetics

The following data is part of a premarket notification filed by Keranetics with the FDA for Kerastat Cream.

Pre-market Notification Details

Device IDK192386
510k NumberK192386
Device Name:KeraStat Cream
ClassificationDressing, Wound, Collagen
Applicant KeraNetics 200 East First Street, Suite 101, Box#4 Winston Salem,  NC  27101
ContactLuke Burnett
CorrespondentLuke Burnett
KeraNetics 200 East First Street, Suite 101, Box#4 Winston Salem,  NC  27101
Product CodeKGN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-03
Decision Date2020-07-16

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