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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name supplies, blood-bank
510(k) Number BK070026
Tradenames GPS III Mini Platelet Concentrate Separation Kit with ACD-A, GPS III Platelet Concentrate Separation Kit with ACD-A, GPS III Platelet Concentrate Separation Kit with ACD-A Double Kit
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 Received05/18/2007
Decision Date 06/06/2007
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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