Device Classification Name |
Lens, Contact (Other Material) - Daily
|
510(k) Number |
K954124 |
Device Name |
O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS |
Applicant |
OPTICAL POLYMER RESEARCH, INC. |
235 NORTH TALBOT CT. |
ROSWELL,
GA
30076 -2480
|
|
Applicant Contact |
WALLY STIRLING |
Correspondent |
OPTICAL POLYMER RESEARCH, INC. |
235 NORTH TALBOT CT. |
ROSWELL,
GA
30076 -2480
|
|
Correspondent Contact |
WALLY STIRLING |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 09/01/1995 |
Decision Date | 03/19/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|