Device Classification Name |
Catheter, Urethral
|
510(k) Number |
K143182 |
FOIA Releasable 510(k) |
K143182
|
Device Name |
Speedicath Compact Male |
Applicant |
COLOPLAST A/S |
1601 WEST RIVER ROAD NORTH |
MINNEAPOLIS,
MN
55411
|
|
Applicant Contact |
Brian Schmidt |
Correspondent |
COLOPLAST A/S |
1601 WEST RIVER ROAD NORTH |
MINNEAPOLIS,
MN
55411
|
|
Correspondent Contact |
Brian Schmidt |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 11/05/2014 |
Decision Date | 01/20/2015 |
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
|
|
|