The following data is part of a premarket notification filed by Gilero, Llc with the FDA for Smartsite Bag 500ml, Smartsite Bag 250 Ml, Smartsite Bag 100 Ml.
| Device ID | K201936 |
| 510k Number | K201936 |
| Device Name: | SmartSite Bag 500mL, SmartSite Bag 250 ML, SmartSite Bag 100 ML |
| Classification | Container, I.v. |
| Applicant | Gilero, LLC 635 Davis Drive, Suite 100 Morrisville, NC 27560 |
| Contact | Kristin Benokraitis |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KPE |
| CFR Regulation Number | 880.5025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-07-13 |
| Decision Date | 2021-05-06 |