MESOTHELIUM DENTAL MEMBRANE

Barrier, Animal Source, Intraoral

KENSEY NASH CORPORATION

The following data is part of a premarket notification filed by Kensey Nash Corporation with the FDA for Mesothelium Dental Membrane.

Pre-market Notification Details

Device IDK121310
510k NumberK121310
Device Name:MESOTHELIUM DENTAL MEMBRANE
ClassificationBarrier, Animal Source, Intraoral
Applicant KENSEY NASH CORPORATION 735 PENNSYLVANIA DRIVE Exton,  PA  19341
ContactLori Burns, Ms, Rac
CorrespondentLori Burns, Ms, Rac
KENSEY NASH CORPORATION 735 PENNSYLVANIA DRIVE Exton,  PA  19341
Product CodeNPL  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-01
Decision Date2013-07-11
Summary:summary

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