Device Classification Name |
Lens, Contact (Other Material) - Daily
|
510(k) Number |
K000795 |
FOIA Releasable 510(k) |
K000795
|
Device Name |
RIGID GAS PERMEABLE CONTACT LENS |
Applicant |
POLYMER TECHNOLOGY |
1400 N GOODMAN ST. |
ROCHESTER,
NY
14692
|
|
Applicant Contact |
DEBRA L.B. KETCHUM |
Correspondent |
POLYMER TECHNOLOGY |
1400 N GOODMAN ST. |
ROCHESTER,
NY
14692
|
|
Correspondent Contact |
DEBRA L.B. KETCHUM |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 03/13/2000 |
Decision Date | 05/26/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|