Device Classification Name |
Catheter, Urethral
|
510(k) Number |
K023254 |
FOIA Releasable 510(k) |
K023254
|
Device Name |
SPEEDICATH |
Applicant |
COLOPLAST CORP. |
1940 COMMERCE DR. |
NORTH MANKATO,
MN
56003
|
|
Applicant Contact |
ELIZABETH BOOTS |
Correspondent |
COLOPLAST CORP. |
1940 COMMERCE DR. |
NORTH MANKATO,
MN
56003
|
|
Correspondent Contact |
ELIZABETH BOOTS |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 09/30/2002 |
Decision Date | 01/27/2003 |
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
|
Recalls |
CDRH Recalls
|
|
|