The following data is part of a premarket notification filed by Ranfac Corp with the FDA for Marrow Cellution Bone Marrow Aspiration Needle.
| Device ID | K150563 |
| 510k Number | K150563 |
| Device Name: | Marrow Cellution Bone Marrow Aspiration Needle |
| Classification | Instrument, Biopsy |
| Applicant | RANFAC CORP 30 DOHERTY AVENUE P.O. BOX 635 Avon, MA 02322 |
| Contact | Christopher P. Whelan |
| Correspondent | Christopher P. Whelan RANFAC CORP 30 DOHERTY AVENUE P.O. BOX 635 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 | 2015-03-06 |
| Decision Date | 2015-05-22 |
| Summary: | summary |