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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name supplies, blood-bank
510(k) Number BK070003
Tradenames GPS II Platelet Concentration Separation Kit with ACD-A, Plasmax Plasma Concentrator with GPS Mini Platelet Concentrate Separation Kit with ACD-A
Device Name Blood Bank Supplies
Original Applicant
Biomet Biologics, Inc.
56 east bell drive
po box 587
warsaw,  IN  46581 0587
Regulation Number864.9050
Classification Product Code
KSS  
Date Received02/02/2007
Decision Date 02/22/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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