Geistlich Wound Matrix

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.

Pre-market Notification Details

Device IDK171842
510k NumberK171842
Device Name:Geistlich Wound Matrix
ClassificationDressing, Wound, Collagen
Applicant Geistlich Pharma AG Bahnhofstrasse 40 Wolhusen,  CH Ch-6110
ContactJan Van Der Ploeg
CorrespondentStephen P. Rhodes
Biologics Consulting Group, Inc 400 N. Washington St. Suite 100 Alexandria,  VA  22314
Product CodeKGN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-20
Decision Date2017-11-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07610221012626 K171842 000
07610221012619 K171842 000
07610221012602 K171842 000

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