Device Classification Name |
shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
|
510(k) Number |
K885163 |
Device Name |
DIOPTICS EYESHIELDS |
Applicant |
DIOPTICS |
15550 ROCKFIELD BLVD., STE. C |
IRVINE,
CA
92714
|
|
Applicant Contact |
ELEANOR LANGLEY |
Correspondent |
DIOPTICS |
15550 ROCKFIELD BLVD., STE. C |
IRVINE,
CA
92714
|
|
Correspondent Contact |
ELEANOR LANGLEY |
Regulation Number | 886.4750
|
Classification Product Code |
|
Date Received | 12/13/1988 |
Decision Date | 12/30/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|