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Blood Establishment Computer Software And Accessories

Kedrion S.p.A.

The following data is part of a premarket notification filed by Kedrion S.p.a. 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 IDBK200456
510k NumberBK200456
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
ClassificationBlood Establishment Computer Software And Accessories
Applicant Kedrion S.p.A. loc. Ai Conti Barga,  Lucca,  55051,  IT
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-03
Decision Date2020-04-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08055271669762 BK200456 0

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