The following data is part of a premarket notification filed by Innovative Health Sciences, Llc with the FDA for Insignis Subcutaneous Needle Sets.
| Device ID | K202279 |
| 510k Number | K202279 |
| Device Name: | Insignis Subcutaneous Needle Sets |
| Classification | Set, Administration, Intravascular |
| Applicant | Innovative Health Sciences, LLC 1108 Kings Highway, Suite 4 Chester, NY 10918 |
| Contact | Andy Sealfon |
| Correspondent | Shepard G. Bentley Innovative Health Sciences, LLC 1108 Kings Highway, Suite 4 Chester, NY 10918 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-11 |
| Decision Date | 2021-08-13 |