Device Classification Name |
keratome, ac-powered
|
510(k) Number |
K002515 |
Device Name |
MEDLOGICS ML 4000, MODEL 4000 |
Applicant |
MED-LOGICS, INC. |
30001 GOLDEN LANTERN #334 |
LAGUNA NIGUEL,
CA
92677
|
|
Applicant Contact |
GARY MOCNIK |
Correspondent |
MED-LOGICS, INC. |
30001 GOLDEN LANTERN #334 |
LAGUNA NIGUEL,
CA
92677
|
|
Correspondent Contact |
GARY MOCNIK |
Regulation Number | 886.4370
|
Classification Product Code |
|
Date Received | 08/15/2000 |
Decision Date | 02/22/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|