Device Classification Name |
Catheter, Retention Type, Balloon
|
510(k) Number |
K935630 |
Device Name |
NORTA |
Applicant |
BEIERSDORF, INC. |
360 MARTIN LUTHER KING DR. |
P.O. BOX 5529 |
NORWALK,
CT
06856
|
|
Applicant Contact |
KENNETH M NICOLL |
Correspondent |
BEIERSDORF, INC. |
360 MARTIN LUTHER KING DR. |
P.O. BOX 5529 |
NORWALK,
CT
06856
|
|
Correspondent Contact |
KENNETH M NICOLL |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 11/23/1993 |
Decision Date | 10/07/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|