The following data is part of a premarket notification filed by Ranfac Corporation with the FDA for Ran-flex-b Bone Marrow Aspiration Needle.
| Device ID | K202287 |
| 510k Number | K202287 |
| Device Name: | Ran-Flex-B Bone Marrow Aspiration Needle |
| Classification | Instrument, Biopsy |
| Applicant | Ranfac Corporation 30 Doherty Street Avon, MA 02322 |
| Contact | Eric Kreuz |
| Correspondent | Eric Kreuz Ranfac Corporation 30 Doherty Street Avon, MA 02322 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-12 |
| Decision Date | 2020-09-18 |