Device Classification Name |
biomicroscope, slit-lamp, ac-powered
|
510(k) Number |
K133755 |
Device Name |
KOWA SL-17 |
Applicant |
KOWA CO. LTD. |
4-14, NIHONBASHI-HONCHO |
3-CHOME |
CHUO-KU, TOKYO,
JP
103-8433
|
|
Applicant Contact |
HIROYUKI KOIDE |
Correspondent |
Kowa Company Ltd. |
3-1 Chofugaoka 3-chome |
Chofu City,
JP
182-0021
|
|
Correspondent Contact |
Nariaki Morita |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 12/09/2013 |
Decision Date | 03/11/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|