Device Classification Name |
biomicroscope, slit-lamp, ac-powered
|
510(k) Number |
K861854 |
Device Name |
OPM SLIT LAMP MODEL P-1 |
Applicant |
OPTEK MEDICO CO., LTD. |
RM.#1108, AL BERGO OCHANOMIZU |
1-19, 2 CHOME, KANDA-SURUGADAI |
CHIYODA-KU TOKYO JAPAN,
JP
|
|
Applicant Contact |
ATSUSHI HIRAYAMA |
Correspondent |
OPTEK MEDICO CO., LTD. |
RM.#1108, AL BERGO OCHANOMIZU |
1-19, 2 CHOME, KANDA-SURUGADAI |
CHIYODA-KU TOKYO JAPAN,
JP
|
|
Correspondent Contact |
ATSUSHI HIRAYAMA |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 05/14/1986 |
Decision Date | 07/11/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|