Device Classification Name |
Dilator, Esophageal
|
510(k) Number |
K002363 |
Device Name |
MEDOVATIONS ESOPHAGEAL DILATOR |
Applicant |
MEDOVATIONS, INC. |
1294 BARCLAY BLVD. |
BUFFALO GROVE,
IL
60089
|
|
Applicant Contact |
MICHAEL J BROWN |
Correspondent |
MEDOVATIONS, INC. |
1294 BARCLAY BLVD. |
BUFFALO GROVE,
IL
60089
|
|
Correspondent Contact |
MICHAEL J BROWN |
Regulation Number | 876.5365
|
Classification Product Code |
|
Date Received | 08/03/2000 |
Decision Date | 11/01/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|