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Blood Establishment Computer Software And Accessories

Fenwal Inc

The following data is part of a premarket notification filed by Fenwal Inc 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 IDBK110025
510k NumberBK110025
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 Fenwal Inc three Corporate Drive 2nd Floor Lake Zurich,  IL  60047
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-20
Decision Date2011-08-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00811137013050 BK110025 0

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