Device Classification Name |
Dilator, Esophageal
|
510(k) Number |
K862000 |
Device Name |
KEYMED FLEXIBLE ESOPHAGEAL DILATORS |
Applicant |
KEYMED, INC. |
KEYMED HOUSE, STOCK ROAD |
SOUTHEND-ON-SEA |
ESSEX SS2 5QH ENGLAND,
GB
|
|
Applicant Contact |
ROGER GRAY |
Correspondent |
KEYMED, INC. |
KEYMED HOUSE, STOCK ROAD |
SOUTHEND-ON-SEA |
ESSEX SS2 5QH ENGLAND,
GB
|
|
Correspondent Contact |
ROGER GRAY |
Regulation Number | 876.5365
|
Classification Product Code |
|
Date Received | 05/23/1986 |
Decision Date | 08/12/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|