Device Classification Name |
catheter, urological
|
510(k) Number |
K000070 |
Device Name |
FLOCATH |
Applicant |
RUSCH INTL. |
TALL PINES PARK |
JAFFREY,
NH
03452
|
|
Applicant Contact |
KARENANN J BROZOWSKI |
Correspondent |
RUSCH INTL. |
TALL PINES PARK |
JAFFREY,
NH
03452
|
|
Correspondent Contact |
KARENANN J BROZOWSKI |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 01/10/2000 |
Decision Date | 02/18/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|