The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Remington Medical, Inc. Automatic Cutting Needle (nac).
| Device ID | K191315 |
| 510k Number | K191315 |
| Device Name: | Remington Medical, Inc. Automatic Cutting Needle (NAC) |
| Classification | Instrument, Biopsy |
| Applicant | Remington Medical, Inc. 6830 Meadowridge Court Alpharetta, GA 30005 |
| Contact | Caitlin Senter |
| Correspondent | Caitlin Senter Remington Medical, Inc. 6830 Meadowridge Court Alpharetta, GA 30005 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-15 |
| Decision Date | 2019-07-12 |