Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K220312 |
Device Name |
Polyfusion IV Administration Sets |
Applicant |
Poly Medicure Limited |
Plot No. PA 010-018, 010-019, Mahindra World City (Jaipur) |
Ltd. |
Jaipur,
IN
302237
|
|
Applicant Contact |
Ramdas Sharma |
Correspondent |
Donawa Lifescience Consluting Srl |
Piazza Albania 10 |
Rome,
IT
00153
|
|
Correspondent Contact |
Roger Gray |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 02/02/2022 |
Decision Date | 04/12/2023 |
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
|
|
|