Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K200425 |
Device Name |
Female Luer Lock Cap |
Applicant |
MedSafety Solutions LLC |
7012 S. Revere Pkwy, Suite 120 |
centennial,
CO
80112
|
|
Applicant Contact |
rich weiskopf |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
saint paul,
MN
55114
|
|
Correspondent Contact |
prithul bom |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 02/20/2020 |
Decision Date | 10/29/2020 |
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
|
|
|