Device Classification Name |
Endoilluminator
|
510(k) Number |
K961036 |
Device Name |
MBI FIBEROPTIC ENDO-ILLUMINATOR |
Applicant |
M.B. INDUSTRIES, INC. |
1707 MADISON AVE. |
GRANITE CITY,
IL
62040
|
|
Applicant Contact |
WAYNE C MOSHER |
Correspondent |
M.B. INDUSTRIES, INC. |
1707 MADISON AVE. |
GRANITE CITY,
IL
62040
|
|
Correspondent Contact |
WAYNE C MOSHER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/14/1996 |
Decision Date | 07/15/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|