Geistlich Mucograft®, Geistlich Mucograft® Seal

Barrier, Animal Source, Intraoral

Geistlich Pharma AG

The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Geistlich Mucograft®, Geistlich Mucograft® Seal.

Pre-market Notification Details

Device IDK210280
510k NumberK210280
Device Name:Geistlich Mucograft®, Geistlich Mucograft® Seal
ClassificationBarrier, Animal Source, Intraoral
Applicant Geistlich Pharma AG Bahnhofstrasse 40 Wolhusen,  CH Ch-6110
ContactMarco Steiner
CorrespondentRoshana Ahmed
TELOS Partners LLC 571 Christina Lake Drive Lakeland,  FL  33813
Product CodeNPL  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-01
Decision Date2021-03-03

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