Scaffolene CL100 Bioresorbable Collagen Matrix

Dressing, Wound, Collagen

Freudenberg Technology Innovation SE & Co. KG

The following data is part of a premarket notification filed by Freudenberg Technology Innovation Se & Co. Kg with the FDA for Scaffolene Cl100 Bioresorbable Collagen Matrix.

Pre-market Notification Details

Device IDK192346
510k NumberK192346
Device Name:Scaffolene CL100 Bioresorbable Collagen Matrix
ClassificationDressing, Wound, Collagen
Applicant Freudenberg Technology Innovation SE & Co. KG Hoehnerweg 2-4 Weinheim,  DE 69469
ContactDenis Reibel
CorrespondentSugato De
Parexel International 4600 East-West Highway, Suite 350 Bethesda,  MD  20814
Product CodeKGN  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical Specialty510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-29
Decision Date2020-02-28

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