510(k) K071934

MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT by Biomet Manufacturing Corp — Product Code JQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2007
Date Received
July 13, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type