Device Classification Name |
endoscopic injection needle, gastroenterology-urology
|
510(k) Number |
K921800 |
Device Name |
COLONOSCOPIC INJECTION NEEDLE, C-323/C-325 |
Applicant |
MILL-ROSE LABORATORY |
7310 CORPORATE BLVD. |
MENTOR,
OH
44060 -4885
|
|
Applicant Contact |
ALAN C POJE |
Correspondent |
MILL-ROSE LABORATORY |
7310 CORPORATE BLVD. |
MENTOR,
OH
44060 -4885
|
|
Correspondent Contact |
ALAN C POJE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/14/1992 |
Decision Date | 02/08/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|