Device Classification Name |
I.V. Start Kit
|
510(k) Number |
K001879 |
Device Name |
INFUSION IV SET |
Applicant |
NIRVI INTL. USA |
467 DIABLO DR. |
PITTSBURG,
PA
15241
|
|
Applicant Contact |
DARSHANA HATHI |
Correspondent |
NIRVI INTL. USA |
467 DIABLO DR. |
PITTSBURG,
PA
15241
|
|
Correspondent Contact |
DARSHANA HATHI |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 06/20/2000 |
Decision Date | 11/20/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|