Device Classification Name |
needle, fistula
|
510(k) Number |
K991623 |
Device Name |
NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA |
Applicant |
NIPRO MEDICAL CORP. |
1384 COPPERFIELD COURT |
LEXINGTON,
KY
40514 -1268
|
|
Applicant Contact |
KAELYN HADLEY |
Correspondent |
NIPRO MEDICAL CORP. |
1384 COPPERFIELD COURT |
LEXINGTON,
KY
40514 -1268
|
|
Correspondent Contact |
KAELYN HADLEY |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 05/11/1999 |
Decision Date | 08/09/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|