Device Classification Name |
catheter, urethral
|
510(k) Number |
K150935 |
Device Name |
SpeediCath Compact Eve |
Applicant |
COLOPLAST A/S |
1601 WEST RIVER ROAD NORTH |
MINNEAPOLIS,
MN
55411
|
|
Applicant Contact |
Meg Daniel |
Correspondent |
COLOPLAST A/S |
1601 WEST RIVER ROAD NORTH |
MINNEAPOLIS,
MN
55411
|
|
Correspondent Contact |
Meg Daniel |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 04/07/2015 |
Decision Date | 07/02/2015 |
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
|
|
|