The following data is part of a premarket notification filed by Intera Oncology, Inc. with the FDA for Intera Refill Kit.
| Device ID | K213823 |
| 510k Number | K213823 |
| Device Name: | Intera Refill Kit |
| Classification | Non-coring (huber) Needle |
| Applicant | Intera Oncology, Inc. 65 Williams Street, Suite 200 Wellesley, MA 02481 |
| Contact | Michael Gaisford |
| Correspondent | Sheila Hemeon-heyer Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002 |
| Product Code | PTI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-08 |
| Decision Date | 2022-03-16 |