Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K880343 |
Device Name |
BURNEY GALLBLADDER CATHETER KIT |
Applicant |
MALLINCKRODT CRITICAL CARE |
675 MCDONNELL BLVD. P.O. BOX |
5840 |
ST LOUIS,
MO
63134
|
|
Applicant Contact |
ROBERT S LAKE |
Correspondent |
MALLINCKRODT CRITICAL CARE |
675 MCDONNELL BLVD. P.O. BOX |
5840 |
ST LOUIS,
MO
63134
|
|
Correspondent Contact |
ROBERT S LAKE |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 01/26/1988 |
Decision Date | 05/01/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|