Device Classification Name |
knife, ophthalmic
|
510(k) Number |
K861491 |
Device Name |
ROPHAE DIAMOND KNIFE |
Applicant |
ROPHAE LENS CO., INC. |
300 BUILDING WEST, SUITE 208 |
3151 3RD AVENUE NORTH |
ST. PETERSBURG,
FL
33713
|
|
Applicant Contact |
DENNIS A THACKRAY |
Correspondent |
ROPHAE LENS CO., INC. |
300 BUILDING WEST, SUITE 208 |
3151 3RD AVENUE NORTH |
ST. PETERSBURG,
FL
33713
|
|
Correspondent Contact |
DENNIS A THACKRAY |
Regulation Number | 886.4350
|
Classification Product Code |
|
Date Received | 04/22/1986 |
Decision Date | 05/28/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|