Device Classification Name |
catheter, urethral
|
510(k) Number |
K161672 |
Device Name |
SpeediCath Flex Coude |
Applicant |
Coloplast Corp. |
1601 West River Road North |
Minneapolis,
MN
55411
|
|
Applicant Contact |
Rebecca S. Roberts |
Correspondent |
Coloplast Corp. |
1601 West River Road North |
Minneapolis,
MN
55411
|
|
Correspondent Contact |
Rebecca S. Roberts |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 06/09/2016 |
Decision Date | 09/29/2016 |
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
|
|
|