The following data is part of a premarket notification filed by Instylla, Inc. with the FDA for Instylla Delivery Kit.
| Device ID | K213632 |
| 510k Number | K213632 |
| Device Name: | Instylla Delivery Kit |
| Classification | Syringe, Piston |
| Applicant | Instylla, Inc. 201 Burlington Road, North Building Bedford, MA 01730 |
| Contact | Jennifer Greer |
| Correspondent | Jennifer Greer Instylla, Inc. 201 Burlington Road, North Building Bedford, MA 01730 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-17 |
| Decision Date | 2022-02-10 |