Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K823428 |
Device Name |
KELLY INFLATABLE T DRAIN |
Applicant |
AKRON CATHETER, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
AKRON CATHETER, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 11/16/1982 |
Decision Date | 01/18/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|