Device Classification Name |
adaptor, shunt
|
510(k) Number |
K893478 |
Device Name |
DA-16 AND DA-24 SHUNT ADAPTERS |
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 | 05/04/1989 |
Decision Date | 06/08/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|