Device Classification Name |
Tube, Feeding
|
510(k) Number |
K870623 |
Device Name |
ENTERAL ADMINISTRATION SET |
Applicant |
PLASCO, INC. |
3849 SWANSON ST. |
GURNEE,
IL
60031 -1225
|
|
Applicant Contact |
MICHAEL S FELES |
Correspondent |
PLASCO, INC. |
3849 SWANSON ST. |
GURNEE,
IL
60031 -1225
|
|
Correspondent Contact |
MICHAEL S FELES |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 02/12/1987 |
Decision Date | 06/26/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|