Device Classification Name |
Collector, Ostomy
|
510(k) Number |
K851679 |
Device Name |
OSTOMY BAGS COLOSTOMY |
Applicant |
DBT MEDICAL LTD. |
14 EAGLE INDUSTRIAL ESTATE |
WITNEY,0X8 7AZ,
GB
|
|
Applicant Contact |
BLACKBURN |
Correspondent |
DBT MEDICAL LTD. |
14 EAGLE INDUSTRIAL ESTATE |
WITNEY,0X8 7AZ,
GB
|
|
Correspondent Contact |
BLACKBURN |
Regulation Number | 876.5900
|
Classification Product Code |
|
Date Received | 04/23/1985 |
Decision Date | 06/27/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|