Device Classification Name |
Catheter, Retention Type, Balloon
|
510(k) Number |
K932809 |
Device Name |
FRANGI-CATH SAFE-RELEASE(TM) CONNECTOR |
Applicant |
EXCALIBUR ENGINEERING CARE OF RMS, INC. |
P.O. BOX 2010 |
PALM HARBOR,
FL
34682
|
|
Applicant Contact |
PATRICK J LAMB |
Correspondent |
EXCALIBUR ENGINEERING CARE OF RMS, INC. |
P.O. BOX 2010 |
PALM HARBOR,
FL
34682
|
|
Correspondent Contact |
PATRICK J LAMB |
Regulation Number | 876.5130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/09/1993 |
Decision Date | 03/17/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|