Device Classification Name |
keratome, battery-powered
|
510(k) Number |
K040297 |
Device Name |
ONEUSE- PLUS MICROKERATOME |
Applicant |
MORIA S.A. |
15 RUE GEORGES BESSE |
ANTONY,
FR
92160
|
|
Applicant Contact |
MELANIE RENAUD-SAMIRI |
Correspondent |
MORIA S.A. |
15 RUE GEORGES BESSE |
ANTONY,
FR
92160
|
|
Correspondent Contact |
MELANIE RENAUD-SAMIRI |
Regulation Number | 886.4370
|
Classification Product Code |
|
Date Received | 02/09/2004 |
Decision Date | 03/31/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|