The following data is part of a premarket notification filed by Medax Unipersonale Srl with the FDA for Medax Unipersonale Srl.
| Device ID | K092338 |
| 510k Number | K092338 |
| Device Name: | MEDAX UNIPERSONALE SRL |
| Classification | Instrument, Biopsy |
| Applicant | MEDAX UNIPERSONALE SRL 3016 N.W. 82ND AVE. Miami, FL 33122 |
| Contact | Flavio Tomassini |
| Correspondent | Flavio Tomassini MEDAX UNIPERSONALE SRL 3016 N.W. 82ND AVE. Miami, FL 33122 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-04 |
| Decision Date | 2011-05-27 |
| Summary: | summary |