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Peripheral Blood Processing Device For Wound Management

RedDress Ltd

The following data is part of a premarket notification filed by Reddress Ltd 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 IDBK200464
510k NumberBK200464
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
ClassificationPeripheral Blood Processing Device For Wound Management
Applicant RedDress Ltd shkedim Street 11 Pardes Hanna,  370110,  IS
Product CodePMQ  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-21
Decision Date2020-03-20

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