Device Classification Name |
Keratome, Ac-Powered
|
510(k) Number |
K981071 |
Device Name |
ML MICROKERATOME |
Applicant |
MED-LOGICS, INC. |
30251 GOLDEN LANTERN |
SUITE E-207 |
LAGUNA NIGUEL,
CA
92677
|
|
Applicant Contact |
BETTY ROSS |
Correspondent |
MED-LOGICS, INC. |
30251 GOLDEN LANTERN |
SUITE E-207 |
LAGUNA NIGUEL,
CA
92677
|
|
Correspondent Contact |
BETTY ROSS |
Regulation Number | 886.4370
|
Classification Product Code |
|
Date Received | 03/24/1998 |
Decision Date | 07/23/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|