Device Classification Name |
device, cystometric, hydraulic
|
510(k) Number |
K952029 |
Device Name |
RUSCH INTERNATIONAL URODYNAMIC CATHETERS |
Applicant |
RUSCH INTL. |
TALL PINES PARK |
JAFFREY,
NH
03452
|
|
Applicant Contact |
NEIL ARMSTRONG |
Correspondent |
RUSCH INTL. |
TALL PINES PARK |
JAFFREY,
NH
03452
|
|
Correspondent Contact |
NEIL ARMSTRONG |
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 05/01/1995 |
Decision Date | 06/13/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|