Device Classification Name |
probe and director, gastro-urology
|
510(k) Number |
K944378 |
Device Name |
ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG |
Applicant |
REGULATORY & MARKETING SERVICES, INC. |
1247 FLORIDA AVE. |
PALM HARBOR,
FL
34682
|
|
Applicant Contact |
PATRICK J LAMB |
Correspondent |
REGULATORY & MARKETING SERVICES, INC. |
1247 FLORIDA AVE. |
PALM HARBOR,
FL
34682
|
|
Correspondent Contact |
PATRICK J LAMB |
Regulation Number | 876.4730
|
Classification Product Code |
|
Date Received | 09/07/1994 |
Decision Date | 02/15/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|