Device Classification Name |
Catheter, Straight
|
510(k) Number |
K172247 |
Device Name |
Magic3 Go Intermittent Urinary Catheter |
Applicant |
C.R. Bard, Inc. |
8195 Industrial Blvd |
Covington,
GA
30014
|
|
Applicant Contact |
Nancy Underwood |
Correspondent |
C.R. Bard, Inc. |
8195 Industrial Blvd |
Covington,
GA
30014
|
|
Correspondent Contact |
Nancy Underwood |
Regulation Number | 876.5130 |
Classification Product Code |
|
Date Received | 07/26/2017 |
Decision Date | 09/20/2017 |
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
|
Predetermined Change Control Plan Authorized |
No
|
Recalls |
CDRH Recalls
|
|
|