Device Classification Name |
Lens, Contact (Other Material) - Daily
|
510(k) Number |
K002703 |
Device Name |
O-PERM 30 |
Applicant |
OPTICAL POLYMER RESEARCH, INC. |
5921 N.E. 38TH ST. |
GAINESVILLE,
FL
32609
|
|
Applicant Contact |
WERNER P SCHUMAN |
Correspondent |
OPTICAL POLYMER RESEARCH, INC. |
5921 N.E. 38TH ST. |
GAINESVILLE,
FL
32609
|
|
Correspondent Contact |
WERNER P SCHUMAN |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 08/30/2000 |
Decision Date | 11/21/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|