Device Classification Name |
dilator, catheter, ureteral
|
510(k) Number |
K170531 |
Device Name |
Ureteral Dilators and Percutaneous Nephrostomy Dilators |
Applicant |
Coloplast Corp |
1601 West River Road North |
Minneapolis,
MN
55411
|
|
Applicant Contact |
Cori Ragan |
Correspondent |
Coloplast Corp |
1601 West River Road North |
Minneapolis,
MN
55411
|
|
Correspondent Contact |
Cori Ragan |
Regulation Number | 876.5470
|
Classification Product Code |
|
Date Received | 02/22/2017 |
Decision Date | 08/17/2017 |
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
|
|
|