Device Classification Name |
catheter, urethral
|
510(k) Number |
K152268 |
Device Name |
VAPRO PLUS POCKET Intermittent Catheter |
Applicant |
HOLLISTER INCORPORATED |
2000 HOLLISTER DR |
LIBERTYVILLE,
IL
60048
|
|
Applicant Contact |
JEANNE LEE |
Correspondent |
HOLLISTER INCORPORATED |
2000 HOLLISTER DR |
LIBERTYVILLE,
IL
60048
|
|
Correspondent Contact |
JEANNE LEE |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 08/11/2015 |
Decision Date | 09/09/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|