Device Classification Name |
Catheter, Retention Type, Balloon
|
510(k) Number |
K944673 |
Device Name |
MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE |
Applicant |
REGULATORY & MARKETING SERVICES, INC. |
P.O. BOX 2308 |
1247 FLORIDA AVENUE |
PALM HARBOR,
FL
34682 -2308
|
|
Applicant Contact |
PATRICK J LAMB |
Correspondent |
REGULATORY & MARKETING SERVICES, INC. |
P.O. BOX 2308 |
1247 FLORIDA AVENUE |
PALM HARBOR,
FL
34682 -2308
|
|
Correspondent Contact |
PATRICK J LAMB |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 09/22/1994 |
Decision Date | 04/10/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|