Geistlich Wound Matrix PLUS

Dressing, Wound, Collagen

Geistlich Pharma AG

The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Geistlich Wound Matrix Plus.

Pre-market Notification Details

Device IDK213607
510k NumberK213607
Device Name:Geistlich Wound Matrix PLUS
ClassificationDressing, Wound, Collagen
Applicant Geistlich Pharma AG Bahnhofstrasse 40 Wolhusen,  CH 6110
ContactErik Wirth
CorrespondentStephen P Rhodes
Streamline Regulatory 3502 Dundee Dr Chevy Chase,  MD  20815
Product CodeKGN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-15
Decision Date2022-04-28

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