Device Classification Name |
dilator, catheter, ureteral
|
510(k) Number |
K851463 |
Device Name |
OLBERT CATHETER SYS FOR URETERAL DILATION |
Applicant |
MEADOX SURGIMED, INC. |
112 BAUER DR. |
OAKLAND,
NJ
07436
|
|
Applicant Contact |
JAMES HARTIGAN |
Correspondent |
MEADOX SURGIMED, INC. |
112 BAUER DR. |
OAKLAND,
NJ
07436
|
|
Correspondent Contact |
JAMES HARTIGAN |
Regulation Number | 876.5470
|
Classification Product Code |
|
Date Received | 04/15/1985 |
Decision Date | 05/23/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|