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Platelet And Plasma Separator For Bone Graft Handling

Harvest Technologies

The following data is part of a premarket notification filed by Harvest Technologies 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 IDBK130068
510k NumberBK130068
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
ClassificationPlatelet And Plasma Separator For Bone Graft Handling
Applicant Harvest Technologies 40 Grissom Road Plymouth,  MA  02360 US
Product CodeORG  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-28
Decision Date2014-03-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05020583514997 BK130068 0
35020583514103 BK130068 0
05020583514706 BK130068 0
05020583514720 BK130068 0
05020583514744 BK130068 0
05020583514751 BK130068 0
05020583514782 BK130068 0
05020583514805 BK130068 0
05020583514829 BK130068 0
05020583514836 BK130068 0
05020583514102 BK130068 0

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