Device Classification Name |
needle, fistula
|
510(k) Number |
K844343 |
Device Name |
TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE |
Applicant |
TOP SURGICAL MANUFACTURERS CO. |
7660 WEST FREMONT AVE. |
LITTLETON,
CO
80123
|
|
Applicant Contact |
TOD IMAMURA |
Correspondent |
TOP SURGICAL MANUFACTURERS CO. |
7660 WEST FREMONT AVE. |
LITTLETON,
CO
80123
|
|
Correspondent Contact |
TOD IMAMURA |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 11/09/1984 |
Decision Date | 01/08/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|