Device Classification Name |
cannula, a-v shunt
|
510(k) Number |
K892666 |
Device Name |
SAF-T-SHUNT, S-300 SERIES |
Applicant |
AKCESS MEDICAL PRODUCTS, INC. |
789 JERSEY AVE. |
NEW BRUNSWICK,
NJ
08901
|
|
Applicant Contact |
BALBIR KAPANY |
Correspondent |
AKCESS MEDICAL PRODUCTS, INC. |
789 JERSEY AVE. |
NEW BRUNSWICK,
NJ
08901
|
|
Correspondent Contact |
BALBIR KAPANY |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 04/13/1989 |
Decision Date | 05/04/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|