Device Classification Name |
saline, vascular access flush
|
510(k) Number |
K214080 |
Device Name |
Pentaflush |
Applicant |
PENTAFERTE ITALIA S.R.L. |
Viale Piane Nocella, 23 |
Campli Teramo,
IT
64012
|
|
Applicant Contact |
Rosa Di Gioia |
Correspondent |
PQE US |
12300 Twinbrook Parkway, Suite 400 4th Floor |
Rockville,
MD
20852
|
|
Correspondent Contact |
Luca Giustini |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 12/27/2021 |
Decision Date | 07/20/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|