Device Classification Name |
Tray, Irrigation, Sterile
|
510(k) Number |
K792082 |
Device Name |
GAVAGE FEEDING SET |
Applicant |
MEDICAL DEVICES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MEDICAL DEVICES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5980 |
Classification Product Code |
|
Date Received | 10/16/1979 |
Decision Date | 11/13/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|