Device Classification Name |
keratome, ac-powered
|
510(k) Number |
K981742 |
Device Name |
ONE UP DISPOSABLE KERATOME HEAD |
Applicant |
MORIA, INC. |
15 RUE GEORGES BESSE |
ANTONY,
FR
92160
|
|
Applicant Contact |
ALAIN DUPRAT |
Correspondent |
MORIA, INC. |
15 RUE GEORGES BESSE |
ANTONY,
FR
92160
|
|
Correspondent Contact |
ALAIN DUPRAT |
Regulation Number | 886.4370
|
Classification Product Code |
|
Date Received | 05/18/1998 |
Decision Date | 08/25/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|