The following data is part of a premarket notification filed by Ranfac Corporation with the FDA for Ranfac Cartilage Biopsy Needle.
| Device ID | K183146 |
| 510k Number | K183146 |
| Device Name: | Ranfac Cartilage 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-13 |
| Decision Date | 2019-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20857878007648 | K183146 | 000 |