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Platelet And Plasma Separator For Bone Graft Handling

Estar Technologies LTD

The following data is part of a premarket notification filed by Estar Technologies 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 IDBK110035
510k NumberBK110035
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 Estar Technologies LTD 420 Lexington Avenue suite 2400 New York,  NY  10170
Product CodeORG  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-18
Decision Date2012-03-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00853602008093 BK110035 0
07290015874120 BK110035 0
07290015874137 BK110035 0
07290015874229 BK110035 0
07290015874311 BK110035 0
07290015874328 BK110035 0
07290015874359 BK110035 0
07290015874373 BK110035 0
07290015874380 BK110035 0
07290015874502 BK110035 0
17290015874202 BK110035 0
07290015874014 BK110035 0

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