The following data is part of a premarket notification filed by Apriomed Ab with the FDA for Apriocore Plus.
| Device ID | K193268 |
| 510k Number | K193268 |
| Device Name: | APrioCore Plus |
| Classification | Instrument, Biopsy |
| Applicant | AprioMed AB Virdings Alle 28 Uppsala, SE 75450 |
| Contact | Katrin Svensson |
| Correspondent | Katrin Svensson AprioMed AB Virdings Alle 28 Uppsala, SE 75450 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-26 |
| Decision Date | 2020-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350031350163 | K193268 | 000 |
| 17350031350064 | K193268 | 000 |
| 17350031350071 | K193268 | 000 |
| 17350031350088 | K193268 | 000 |
| 17350031350095 | K193268 | 000 |
| 17350031350101 | K193268 | 000 |
| 17350031350118 | K193268 | 000 |
| 17350031350125 | K193268 | 000 |
| 17350031350132 | K193268 | 000 |
| 17350031350149 | K193268 | 000 |
| 17350031350156 | K193268 | 000 |
| 17350031350057 | K193268 | 000 |