Device Classification Name |
Endoscopic Injection Needle, Gastroenterology-Urology
|
510(k) Number |
K090217 |
Device Name |
BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 |
Applicant |
COLOPLAST A/S |
1601 WEST RIVER ROAD N |
MINNEAPOLIS,
MN
55411
|
|
Applicant Contact |
SURESH GHAL |
Correspondent |
COLOPLAST A/S |
1601 WEST RIVER ROAD N |
MINNEAPOLIS,
MN
55411
|
|
Correspondent Contact |
SURESH GHAL |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/29/2009 |
Decision Date | 04/23/2009 |
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
|
|
|