Device Classification Name |
dilator, catheter, ureteral
|
510(k) Number |
K945576 |
Device Name |
MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R) |
Applicant |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
112 BAUER DR. |
OAKLAND,
NJ
07436
|
|
Applicant Contact |
STEPHEN B ANDERSON |
Correspondent |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
112 BAUER DR. |
OAKLAND,
NJ
07436
|
|
Correspondent Contact |
STEPHEN B ANDERSON |
Regulation Number | 876.5470
|
Classification Product Code |
|
Date Received | 11/14/1994 |
Decision Date | 01/24/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|