Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name centrifuges (micro, ultra, refrigerated) for clinical use
510(k) Number BK090008
Tradename MarrowStim Concentration System
Device Name Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Original Applicant
Biomet Biologics, Inc.
56 east bell drive
po box 587
warsaw,  IN  46581 0587
Regulation Number862.2050
Classification Product Code
JQC  
Date Received02/02/2009
Decision Date 12/18/2009
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
-
-