Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K901683 |
Device Name |
IMPROVED BAKER TWIN-CUFF SUMP TUBE |
Applicant |
BISSELL MEDICAL PRODUCTS, INC. |
608 SOUTH WASHINGTON ST. # |
201 |
NAPERVILLE,
IL
60540
|
|
Applicant Contact |
SHARYL A DEWANE |
Correspondent |
BISSELL MEDICAL PRODUCTS, INC. |
608 SOUTH WASHINGTON ST. # |
201 |
NAPERVILLE,
IL
60540
|
|
Correspondent Contact |
SHARYL A DEWANE |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 04/10/1990 |
Decision Date | 06/27/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|