Device Classification Name |
catheter, retention type, balloon
|
510(k) Number |
K090262 |
Device Name |
PERCUCATH URINARY CATHETER |
Applicant |
PERCUVISION LLC |
765 NORTH HAMILTON RD. |
SUITE 260A |
GAHANNA,
OH
43230
|
|
Applicant Contact |
ERROL SINGH |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
12 LABORATORY DR. |
RESEARCH TRIANGLE,
NC
27709
|
|
Correspondent Contact |
JEFF D RONGERO |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 02/03/2009 |
Decision Date | 05/28/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|