Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K922567 |
Device Name |
LOW PROFILE CATHETER |
Applicant |
RUSCH, INC. |
TALL PINES PARK |
JAFFREY,
NH
03452
|
|
Applicant Contact |
J BROZOWSKI |
Correspondent |
RUSCH, INC. |
TALL PINES PARK |
JAFFREY,
NH
03452
|
|
Correspondent Contact |
J BROZOWSKI |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 06/01/1992 |
Decision Date | 11/21/1995 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|