Device Classification Name |
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
|
510(k) Number |
K900942 |
Device Name |
OCULAR OCCLUDER |
Applicant |
MICRODYNAMICS |
9037 ARROW ROUTE |
SUITE 100 |
RANCHO CUCAMONGA,
CA
91730
|
|
Applicant Contact |
RICHARD ROTHERMUND |
Correspondent |
MICRODYNAMICS |
9037 ARROW ROUTE |
SUITE 100 |
RANCHO CUCAMONGA,
CA
91730
|
|
Correspondent Contact |
RICHARD ROTHERMUND |
Regulation Number | 886.4750
|
Classification Product Code |
|
Date Received | 02/28/1990 |
Decision Date | 05/25/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|