The following data is part of a premarket notification filed by Biopsybell S.r.l. with the FDA for Marrow-pack (white)- 11gauge/10cm Or 13gauge/10cm, Marrow-tray (red)- 11gauge/10cm Or 13gauge/10cm, Marrow-set (violet)- 11gauge/10cm Or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm Or 13gauge/10cm, Marrow-stem (green)- 11gauge/10cm Or 13gauge/10cm.
| Device ID | K203397 |
| 510k Number | K203397 |
| Device Name: | Marrow-Pack (white)- 11gauge/10cm Or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm Or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm Or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm Or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm Or 13gauge/10cm |
| Classification | Instrument, Biopsy |
| Applicant | Biopsybell S.r.l. Via A. Manuzio, 24 Mirandola, IT 41037 |
| Contact | Carlo Ricca Prandi Bellini |
| Correspondent | Maurizio Pantaleoni Maytal Doo Kneza Milosa, 79 Belgrade, RS 11000 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-18 |
| Decision Date | 2021-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033860036317 | K203397 | 000 |
| 08033860036621 | K203397 | 000 |
| 08033860036638 | K203397 | 000 |
| 08033860036645 | K203397 | 000 |
| 08033860036652 | K203397 | 000 |
| 08033860036669 | K203397 | 000 |
| 08033860036676 | K203397 | 000 |
| 08033860036683 | K203397 | 000 |
| 08033860036690 | K203397 | 000 |
| 08033860036324 | K203397 | 000 |