Device Classification Name |
Cannula, A-V Shunt
|
510(k) Number |
K831801 |
Device Name |
HEMOCLAV VENOUS CATHETER |
Applicant |
EXO, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
EXO, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 06/03/1983 |
Decision Date | 07/07/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|