The following data is part of a premarket notification filed by Stemcor Systems, Inc. with the FDA for Marrowminer.
| Device ID | K071732 |
| 510k Number | K071732 |
| Device Name: | MARROWMINER |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | STEMCOR SYSTEMS, INC. 5582 CHALON ROAD Yorba Linda, CA 92886 |
| Contact | Sharon Rockwell |
| Correspondent | Sharon Rockwell STEMCOR SYSTEMS, INC. 5582 CHALON ROAD Yorba Linda, CA 92886 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-26 |
| Decision Date | 2007-09-24 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MARROWMINER 86491824 4909870 Live/Registered |
RegenMed Systems, Inc. 2014-12-29 |
![]() MARROWMINER 77049272 3528045 Dead/Cancelled |
StemCor Systems, Inc. 2006-11-21 |