Device Classification Name |
Catheter, Coude
|
510(k) Number |
K222279 |
Device Name |
Rusch Intermittent Urethral Catheters |
Applicant |
Teleflex Medical |
3015 Carrington Mill Blvd |
Morrisville,
NC
27560
|
|
Applicant Contact |
Kelly Breheim |
Correspondent |
Teleflex Medical |
3015 Carrington Mill Blvd |
Morrisville,
NC
27560
|
|
Correspondent Contact |
Kelly Breheim |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 07/29/2022 |
Decision Date | 08/29/2022 |
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
|
|
|