Device Classification Name |
Catheter, Urethral
|
510(k) Number |
K180824 |
Device Name |
VaPro 2 Intermittent Catheter |
Applicant |
Hollister Incorporated |
2000 Hollister Drive |
Libertyville,
IL
60048
|
|
Applicant Contact |
Michelle Schiltz-Taing |
Correspondent |
Hollister Incorporated |
2000 Hollister Drive |
Libertyville,
IL
60048
|
|
Correspondent Contact |
Michelle Schiltz-Taing |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 03/30/2018 |
Decision Date | 06/22/2018 |
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
|
|
|