Device Classification Name |
Endoscopic Injection Needle, Gastroenterology-Urology
|
510(k) Number |
K091391 |
Device Name |
UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 |
Applicant |
UROPLASTY, INC. |
5420 FELTL RD. |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
MICHAEL MORRELL |
Correspondent |
UROPLASTY, INC. |
5420 FELTL RD. |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
MICHAEL MORRELL |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 05/11/2009 |
Decision Date | 06/30/2009 |
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
|
|
|