Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K002031 |
Device Name |
PHACOFRAGMENTATION SYSTEM MEGATRON |
Applicant |
ASCLEPION-MEDITEC AG |
2525 MC GAW AVE. |
IRVINE,
CA
92623 -9791
|
|
Applicant Contact |
WILLIAM KELLEY |
Correspondent |
ASCLEPION-MEDITEC AG |
2525 MC GAW AVE. |
IRVINE,
CA
92623 -9791
|
|
Correspondent Contact |
WILLIAM KELLEY |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 07/03/2000 |
Decision Date | 12/27/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|