Device Classification Name |
needle, fistula
|
510(k) Number |
K910734 |
Device Name |
MEDISYSTEMS HEMODIALYSIS FISTULA SET |
Applicant |
MEDISYSTEMS CORP. |
21ST FLOOR |
345 CALIFORNIA STREET |
SAN FRANCISCO,
CA
94104
|
|
Applicant Contact |
ALAN C HINTON |
Correspondent |
MEDISYSTEMS CORP. |
21ST FLOOR |
345 CALIFORNIA STREET |
SAN FRANCISCO,
CA
94104
|
|
Correspondent Contact |
ALAN C HINTON |
Regulation Number | 876.5540
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/21/1991 |
Decision Date | 06/20/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|