Device Classification Name |
Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
|
510(k) Number |
K842679 |
Device Name |
ESOPHAGEAL DILATOR SET |
Applicant |
MILL-ROSE LABORATORY |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MILL-ROSE LABORATORY |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5365
|
Classification Product Code |
|
Date Received | 07/10/1984 |
Decision Date | 10/02/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|