Device Classification Name |
keratome, ac-powered
|
510(k) Number |
K960395 |
Device Name |
PLANCON MIRCOLAMELLAR KERATOME |
Applicant |
PLANCON INSTRUMENTS |
15 RUE GEORGES BESSE |
ANTHONY,
FR
92160
|
|
Applicant Contact |
ALAIN DUPRAT |
Correspondent |
PLANCON INSTRUMENTS |
15 RUE GEORGES BESSE |
ANTHONY,
FR
92160
|
|
Correspondent Contact |
ALAIN DUPRAT |
Regulation Number | 886.4370
|
Classification Product Code |
|
Date Received | 01/29/1996 |
Decision Date | 04/26/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|