FDA.report

510(k) K211554

Device
InnoGenic Non-resorbable Membrane
Applicant
Cowellmedi Co., Ltd.
510(k) number
K211554
Product code
NPK
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-24
Date received
2021-05-19
Regulation
872.3930
Classification name
Barrier, Synthetic, Intraoral
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Minjin Park
Address
48, Hakgam-Daero 221beon-Gil, Sasang-Gu Busan KR 46986 46986

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
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08800016107159InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,Ltd2024-05-24
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K082111STRAUMANN MEMBRAGELInstitut Straumann AG2009-05-22
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K033074INION GTR BIODEGRADABLE MEMBRANE SYSTEMInion , Ltd.2004-03-31