Device Classification Name |
chair, ophthalmic, ac-powered
|
510(k) Number |
K864574 |
Device Name |
MAC 150E OPTHALMIC CHAIR |
Applicant |
KOKEN MFG COMPANY, INC. |
1631 M.L. KING DR. |
ST. LOUIS,
MO
63106
|
|
Applicant Contact |
MASAYA KOSAKA |
Correspondent |
KOKEN MFG COMPANY, INC. |
1631 M.L. KING DR. |
ST. LOUIS,
MO
63106
|
|
Correspondent Contact |
MASAYA KOSAKA |
Regulation Number | 886.1140
|
Classification Product Code |
|
Date Received | 11/20/1986 |
Decision Date | 12/15/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|