Device Classification Name |
Esophagoscope (Flexible Or Rigid)
|
510(k) Number |
K951424 |
Device Name |
M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM |
Applicant |
M.E.R. SURGICAL CO. |
773 TROTTER COURT |
WALNUT,
CA
91789
|
|
Applicant Contact |
WILLIAM MEYER |
Correspondent |
M.E.R. SURGICAL CO. |
773 TROTTER COURT |
WALNUT,
CA
91789
|
|
Correspondent Contact |
WILLIAM MEYER |
Regulation Number | 874.4710
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/27/1995 |
Decision Date | 05/09/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|