Device Classification Name |
cystometric gas (carbon-dioxide) on hydraulic device
|
510(k) Number |
K962472 |
Device Name |
RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER |
Applicant |
RUSCH INTL. |
TALL PINES PARK |
JAFFREY,
NH
03452
|
|
Applicant Contact |
NEIL R ARMSTRONG |
Correspondent |
RUSCH INTL. |
TALL PINES PARK |
JAFFREY,
NH
03452
|
|
Correspondent Contact |
NEIL R ARMSTRONG |
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 06/25/1996 |
Decision Date | 08/27/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|