Device Classification Name |
dilator, esophageal
|
510(k) Number |
K881478 |
Device Name |
MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS |
Applicant |
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. |
KEYMED HOUSE,STOCK ROAD |
SOUTHEND-ON-SEA, ESSEX SS2 5QH |
ESSEX,
GB
|
|
Applicant Contact |
ROGER GRAY |
Correspondent |
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. |
KEYMED HOUSE,STOCK ROAD |
SOUTHEND-ON-SEA, ESSEX SS2 5QH |
ESSEX,
GB
|
|
Correspondent Contact |
ROGER GRAY |
Regulation Number | 876.5365
|
Classification Product Code |
|
Date Received | 04/06/1988 |
Decision Date | 09/14/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|