Device Classification Name |
Container, I.V.
|
510(k) Number |
K201936 |
Device Name |
SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL |
Applicant |
Gilero, LLC |
635 Davis Drive, Suite 100 |
Morrisville,
NC
27560
|
|
Applicant Contact |
Kristin Benokraitis |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 880.5025
|
Classification Product Code |
|
Date Received | 07/13/2020 |
Decision Date | 05/06/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|