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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
510(k) Number K071934
Device Name MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
Applicant
Biomet Manufacturing Corp
56 E. Bell Dr.
Warsaw,  IN  46582
Applicant Contact MARY L VERSTYNEN
Correspondent
Biomet Manufacturing Corp
56 E. Bell Dr.
Warsaw,  IN  46582
Correspondent Contact MARY L VERSTYNEN
Regulation Number862.2050
Classification Product Code
JQC  
Date Received07/13/2007
Decision Date 10/11/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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