Device Classification Name |
Lacrimal Stents And Intubation Sets
|
510(k) Number |
K120886 |
Device Name |
LACRIFAST |
Applicant |
HIROYASU HIGUCHI |
4-1 17 HONGO, BUNKYO-KU |
TOKYO,
JP
113-0033
|
|
Applicant Contact |
FUMIAKI KANAI, PH.D. |
Correspondent |
HIROYASU HIGUCHI |
4-1 17 HONGO, BUNKYO-KU |
TOKYO,
JP
113-0033
|
|
Correspondent Contact |
FUMIAKI KANAI, PH.D. |
Classification Product Code |
|
Date Received | 03/23/2012 |
Decision Date | 12/17/2012 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|