Device Classification Name |
dilator, esophageal
|
510(k) Number |
K853274 |
Device Name |
AMERICAN DILATATION SYSTEM |
Applicant |
AMERICAN ENDOSCOPY, INC. |
9350 PROGRESS PKWY. |
MENTOR,
OH
44060
|
|
Applicant Contact |
MARLIN E YOUNKER |
Correspondent |
AMERICAN ENDOSCOPY, INC. |
9350 PROGRESS PKWY. |
MENTOR,
OH
44060
|
|
Correspondent Contact |
MARLIN E YOUNKER |
Regulation Number | 876.5365
|
Classification Product Code |
|
Date Received | 08/05/1985 |
Decision Date | 10/17/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|