Device Classification Name |
catheter, urological
|
510(k) Number |
K183335 |
Device Name |
Medline Poly-Cath Red Polymer Urethral Catheter |
Applicant |
Medline Industries, Inc. |
Three Lakes Drive |
Northfield,
IL
60093
|
|
Applicant Contact |
Dinah Rincones |
Correspondent |
Medline Industries, Inc. |
Three Lakes Drive |
Northfield,
IL
60093
|
|
Correspondent Contact |
Dinah Rincones |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 12/03/2018 |
Decision Date | 06/12/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|