Device Classification Name |
Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
|
510(k) Number |
K901425 |
Device Name |
PYLORIC BALLOON DILATOR |
Applicant |
TELEMED SYSTEMS, INC. |
8 KANE INDUSTRIAL DR. |
HUDSON,
MA
01749
|
|
Applicant Contact |
JOHN A CHAVES |
Correspondent |
TELEMED SYSTEMS, INC. |
8 KANE INDUSTRIAL DR. |
HUDSON,
MA
01749
|
|
Correspondent Contact |
JOHN A CHAVES |
Regulation Number | 876.5365
|
Classification Product Code |
|
Date Received | 03/26/1990 |
Decision Date | 06/21/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|