Device Classification Name |
Biomicroscope, Slit-Lamp, Ac-Powered
|
510(k) Number |
K063640 |
Device Name |
KOWA SL-15 |
Applicant |
KOWA CO. LTD. |
4-14, NIHONBASHI-HONCHO |
3-CHOME |
CHUO-KU, TOKYO,
JP
103-8433
|
|
Applicant Contact |
SATOHIKO TAKANASHI |
Correspondent |
KOWA CO. LTD. |
4-14, NIHONBASHI-HONCHO |
3-CHOME |
CHUO-KU, TOKYO,
JP
103-8433
|
|
Correspondent Contact |
SATOHIKO TAKANASHI |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 12/07/2006 |
Decision Date | 12/18/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|