The following data is part of a premarket notification filed by Instylla, Inc. with the FDA for Instylla Delivery Kit.
| Device ID | K191659 |
| 510k Number | K191659 |
| Device Name: | Instylla Delivery Kit |
| Classification | Syringe, Piston |
| Applicant | Instylla, Inc. 204 Second Avenue Waltham, MA 02451 |
| Contact | Amita Smith |
| Correspondent | Amita Smith Instylla, Inc. 204 Second Avenue Waltham, MA 02451 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-21 |
| Decision Date | 2019-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812013030000 | K191659 | 000 |