The following data is part of a premarket notification filed by Ranfac Corporation with the FDA for J-type Marrow Biopsy Needle,t-type Marrow Biopsy Needle,tweezer Bone Marrow Biopsy Needle,.
| Device ID | K190177 |
| 510k Number | K190177 |
| Device Name: | J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, |
| Classification | Instrument, Biopsy |
| Applicant | Ranfac Corporation 30 Doherty Ave Avon, MA 02322 |
| Contact | Eric Kreuz |
| Correspondent | Eric Kreuz Ranfac Corporation 30 Doherty Ave Avon, MA 02322 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-01 |
| Decision Date | 2019-06-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812593021559 | K190177 | 000 |
| 00812593021542 | K190177 | 000 |
| 00812593021566 | K190177 | 000 |