Device Classification Name |
Catheter, Urethral
|
510(k) Number |
K121458 |
Device Name |
SPEEDICATH COMPACT SET (12/18 FR) |
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 | 05/16/2012 |
Decision Date | 10/01/2012 |
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
|
|
|