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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10857878007313 | K150563 | 000 |
| 10850023741469 | K150563 | 000 |
| 10850023741476 | K150563 | 000 |
| 10850023741483 | K150563 | 000 |
| 10850023741490 | K150563 | 000 |
| 00850023741509 | K150563 | 000 |
| 10850023741445 | K150563 | 000 |
| 10850023741223 | K150563 | 000 |
| 10850023741247 | K150563 | 000 |
| 10850023741452 | K150563 | 000 |
| 10850023741537 | K150563 | 000 |
| 10850023741520 | K150563 | 000 |
| 10850023741957 | K150563 | 000 |
| 10850023741940 | K150563 | 000 |
| 10850023741902 | K150563 | 000 |
| 10850023741773 | K150563 | 000 |
| 10858690006140 | K150563 | 000 |
| 10858690006157 | K150563 | 000 |
| 00850023741585 | K150563 | 000 |
| 10850023741513 | K150563 | 000 |
| 10850023741155 | K150563 | 000 |
| 10850023741087 | K150563 | 000 |
| 00857878007828 | K150563 | 000 |
| 00857878007453 | K150563 | 000 |
| 20858690006079 | K150563 | 000 |
| 20858690006086 | K150563 | 000 |
| 00858690006211 | K150563 | 000 |
| 00858690006228 | K150563 | 000 |
| 20858690006253 | K150563 | 000 |
| 20858690006284 | K150563 | 000 |
| 00858690006334 | K150563 | 000 |
| 20857878007358 | K150563 | 000 |
| 20857878007273 | K150563 | 000 |
| 20857878007204 | K150563 | 000 |
| 20858690006000 | K150563 | 000 |
| 20858690006017 | K150563 | 000 |
| 10857878007948 | K150563 | 000 |
| 10857878007931 | K150563 | 000 |
| 20857878007037 | K150563 | 000 |
| 20857878007082 | K150563 | 000 |
| 20857878007099 | K150563 | 000 |
| 20857878007198 | K150563 | 000 |
| 20858690006703 | K150563 | 000 |