Device Classification Name |
endoscopic access overtube, gastroenterology-urology
|
510(k) Number |
K140523 |
Device Name |
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM |
Applicant |
COLOPLAST A/S |
1601 WEST RIVER ROAD N |
MINNEAPOLIS,
MN
55411
|
|
Applicant Contact |
BRIAN SCHMIDT |
Correspondent |
COLOPLAST A/S |
1601 WEST RIVER ROAD N |
MINNEAPOLIS,
MN
55411
|
|
Correspondent Contact |
BRIAN SCHMIDT |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/04/2014 |
Decision Date | 07/24/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|