Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K940084 |
Device Name |
MODEL 2000 OPHTHALMIC SURGICAL SYSTEM |
Applicant |
MEDICAL TECHNICAL PRODUCTS |
23042 ALCALDE, SUITE A |
LAGUNA HILLS,
CA
92653
|
|
Applicant Contact |
JAMES H BAKOS |
Correspondent |
MEDICAL TECHNICAL PRODUCTS |
23042 ALCALDE, SUITE A |
LAGUNA HILLS,
CA
92653
|
|
Correspondent Contact |
JAMES H BAKOS |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 01/07/1994 |
Decision Date | 06/17/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|