The following data is part of a premarket notification filed by Mermaid Medical A/s with the FDA for M-biopsy Semi-automatic Biopsy Instrument M-biopsy Coaxial Introducer Needle For Sem.
| Device ID | K161409 |
| 510k Number | K161409 |
| Device Name: | M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle For Sem |
| Classification | Instrument, Biopsy |
| Applicant | Mermaid Medical A/S Frydensbergvej 25 Stenloese, DK Dk3660 |
| Contact | Pia Wissing Jensen |
| Correspondent | Rhonda Alexander Registrar Corp 144 Research Drive Hampton, VA 23666 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-20 |
| Decision Date | 2016-08-02 |
| Summary: | summary |