MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT

Centrifuges (micro, Ultra, Refrigerated) For Clinical Use

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Marrowstim Concentration Kit And Marrowstim Mini Concentration Kit.

Pre-market Notification Details

Device IDK071934
510k NumberK071934
Device Name:MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
ClassificationCentrifuges (micro, Ultra, Refrigerated) For Clinical Use
Applicant BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw,  IN  46582
ContactMary L Verstynen
CorrespondentMary L Verstynen
BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw,  IN  46582
Product CodeJQC  
CFR Regulation Number862.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-13
Decision Date2007-10-11
Summary:summary

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