Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K093653 |
Device Name |
URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK |
Applicant |
URESIL, LLC |
5418 WEST TOUHY AVE. |
SKOKIE,
IL
60077
|
|
Applicant Contact |
LEV MELINYSHYN |
Correspondent |
URESIL, LLC |
5418 WEST TOUHY AVE. |
SKOKIE,
IL
60077
|
|
Correspondent Contact |
LEV MELINYSHYN |
Regulation Number | 876.5980 |
Classification Product Code |
|
Date Received | 11/25/2009 |
Decision Date | 02/23/2010 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|