Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K964018 |
Device Name |
PHACOILLUMINATOR - FIBEROPTIC SLEEVE |
Applicant |
MICHAEL REYNARD, M.D. |
1301-20TH ST., #260 |
SANTA MONICA,
CA
90404
|
|
Applicant Contact |
MICHAEL REYNARD |
Correspondent |
MICHAEL REYNARD, M.D. |
1301-20TH ST., #260 |
SANTA MONICA,
CA
90404
|
|
Correspondent Contact |
MICHAEL REYNARD |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 10/07/1996 |
Decision Date | 02/26/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|