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.
Device ID | K071934 |
510k Number | K071934 |
Device Name: | MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT |
Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw, IN 46582 |
Contact | Mary L Verstynen |
Correspondent | Mary L Verstynen BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw, IN 46582 |
Product Code | JQC |
CFR Regulation Number | 862.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-13 |
Decision Date | 2007-10-11 |
Summary: | summary |