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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name platelet and plasma separator for bone graft handling
510(k) Number BK110035
Tradename TropoCells Autologous Platelet Preparation Kit
Original Applicant
Estar Technologies LTD
420 lexington avenue
suite 2400
new york,  NY  10170
Current 510(k) Holder *
Eclipse MedCorp LLC
5916 stone creek drive
suite 120
the colony,  TX  75056
Current 510(k) Contact * paul o'brien
Regulation Number864.9245
Classification Product Code
Date Received07/18/2011
Decision Date 03/28/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
* Based on currently available data in Establishment Registration and Device Listing