Device Classification Name |
lens, contact, polymethylmethacrylate, diagnostic
|
510(k) Number |
K914117 |
Device Name |
LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET |
Applicant |
OCULAR INSTRUMENTS, INC. |
2255 116TH AVE., N.E. |
BELLEVUE,
WA
98004 -3039
|
|
Applicant Contact |
TAMSIN J ERICKSON |
Correspondent |
OCULAR INSTRUMENTS, INC. |
2255 116TH AVE., N.E. |
BELLEVUE,
WA
98004 -3039
|
|
Correspondent Contact |
TAMSIN J ERICKSON |
Regulation Number | 886.1385
|
Classification Product Code |
|
Date Received | 09/13/1991 |
Decision Date | 11/13/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|