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Microfilter, Blood Transfusion

Haemonetics Manufacturing Inc.

The following data is part of a premarket notification filed by Haemonetics Manufacturing 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 IDBK050015
510k NumberBK050015
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
ClassificationMicrofilter, Blood Transfusion
Applicant Haemonetics Manufacturing Inc. 400 Wood Road Braintree,  MA  02184
Product CodeCAK  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-22
Decision Date2005-04-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30887691308742 BK050015 0

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