Device Classification Name |
Keratome, Ac-Powered
|
510(k) Number |
K001806 |
Device Name |
REFRACTIVE SURGERY BLADES |
Applicant |
MILLENNIUM BIOMEDICAL, INC. |
360 EAST BONITA AVE. |
POMONA,
CA
91767
|
|
Applicant Contact |
JERRY KAENI |
Correspondent |
MILLENNIUM BIOMEDICAL, INC. |
360 EAST BONITA AVE. |
POMONA,
CA
91767
|
|
Correspondent Contact |
JERRY KAENI |
Regulation Number | 886.4370 |
Classification Product Code |
|
Date Received | 06/15/2000 |
Decision Date | 09/12/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|