Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K230616 |
Device Name |
Polyguard and Polyshield Safety IV Catheters |
Applicant |
Poly Medicure Limited |
Plot No. 115-116, Sector-59, HSIIDC Industrial Area, |
Ballabgarh |
Faridabad,
IN
121004
|
|
Applicant Contact |
Ramdas Sharma |
Correspondent |
Donawa Lifescience Consulting Srl |
Piazza Albania 10 |
Rome,
IT
00153
|
|
Correspondent Contact |
Roger Gray |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 03/06/2023 |
Decision Date | 05/05/2023 |
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
|
|
|