Device Classification Name |
Lens, Contact, Polymethylmethacrylate, Diagnostic
|
510(k) Number |
K941420 |
Device Name |
50 DEGREE HRI PRISM LENS |
Applicant |
OCULAR INSTRUMENTS, INC. |
2255 116TH AVE., N.E. |
BELLEVUE,
WA
98004 -3039
|
|
Applicant Contact |
PHILLIP J ERICKSON |
Correspondent |
OCULAR INSTRUMENTS, INC. |
2255 116TH AVE., N.E. |
BELLEVUE,
WA
98004 -3039
|
|
Correspondent Contact |
PHILLIP J ERICKSON |
Regulation Number | 886.1385
|
Classification Product Code |
|
Date Received | 03/23/1994 |
Decision Date | 08/29/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|