The following data is part of a premarket notification filed by Neodynamics Ab with the FDA for Neonavia Biopsy System.
| Device ID | K220595 |
| 510k Number | K220595 |
| Device Name: | NeoNavia Biopsy System |
| Classification | Instrument, Biopsy |
| Applicant | NeoDynamics AB Lejonvagen 14 Lidingo, SE SE-181 32 |
| Contact | Anna Forsberg |
| Correspondent | LeAnn Latham M Squared Associates,Inc. 127 West 30th Street, 9th Floor New York, NY 10001 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-01 |
| Decision Date | 2022-09-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27350081940083 | K220595 | 000 |
| 27350081940076 | K220595 | 000 |
| 27350081940045 | K220595 | 000 |