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 |