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Cord Blood Processing System And Storage Container

ThermoGenesis Corp

The following data is part of a premarket notification filed by Thermogenesis 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 IDBK180198
510k NumberBK180198
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
ClassificationCord Blood Processing System And Storage Container
Applicant ThermoGenesis Corp 2700 Citrus Rd Ranco Cordova,  CA  75741 US
Product CodeOAO  
CFR Regulation Number864.9900 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-30
Decision Date2018-11-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00886368000544 BK180198 0
00886368000285 BK180198 0
00886368000667 BK180198 0
00886368000612 BK180198 0

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