The following data is part of a premarket notification filed by Somatex Medical Technologies Gmbh with the FDA for Biopsy Handy, Mri Biopsy Handy.
| Device ID | K102771 |
| 510k Number | K102771 |
| Device Name: | BIOPSY HANDY, MRI BIOPSY HANDY |
| Classification | Instrument, Biopsy |
| Applicant | SOMATEX MEDICAL TECHNOLOGIES GMBH 1480 CAMBRIDGE STREET Cambridge, MA 02139 |
| Contact | Susanne Raab |
| Correspondent | Susanne Raab SOMATEX MEDICAL TECHNOLOGIES GMBH 1480 CAMBRIDGE STREET Cambridge, MA 02139 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-24 |
| Decision Date | 2011-06-24 |
| Summary: | summary |