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Platelet And Plasma Separator For Bone Graft Handling

Aeon Biotherapeutics Corp.

The following data is part of a premarket notification filed by Aeon Biotherapeutics Corp. with the FDA for 510(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 .

Pre-market Notification Details

Device IDBK190393
510k NumberBK190393
Device Name:510(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
ClassificationPlatelet And Plasma Separator For Bone Graft Handling
Applicant Aeon Biotherapeutics Corp. 12f., No.58, Ruihu St. Taipei City,  Neihu Dist,  11494,  TW
Product CodeORG  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-11
Decision Date2020-06-05

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