The following data is part of a premarket notification filed by Medax Srl Unipersonale with the FDA for Medax Biopsy Systems Iii.
| Device ID | K181803 |
| 510k Number | K181803 |
| Device Name: | Medax Biopsy Systems III |
| Classification | Instrument, Biopsy |
| Applicant | Medax Srl Unipersonale Via R.Piva, 1/A Poggio Rusco, IT 46025 |
| Contact | Stefano Cavalieri |
| Correspondent | Serena Coronati Coronati Consulting Srl Via Luigi Gavioli, 3 Mirandola, IT 41037 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-05 |
| Decision Date | 2018-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18059174749375 | K181803 | 000 |
| 18059174749368 | K181803 | 000 |
| 18055002906583 | K181803 | 000 |
| 18053329372029 | K181803 | 000 |