Device Classification Name |
Endoscopic Injection Needle, Gastroenterology-Urology
|
510(k) Number |
K022484 |
Device Name |
COOK INJECTION NEEDLE |
Applicant |
COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. |
P.O. BOX 227 |
SPENCER,
IN
47460
|
|
Applicant Contact |
DEBBIE SCHMITT |
Correspondent |
COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. |
P.O. BOX 227 |
SPENCER,
IN
47460
|
|
Correspondent Contact |
DEBBIE SCHMITT |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/29/2002 |
Decision Date | 10/25/2002 |
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
|
|
|