Device Classification Name |
Lens, Contact (Other Material) - Daily
|
510(k) Number |
K942533 |
FOIA Releasable 510(k) |
K942533
|
Device Name |
NOVALENS/NOVAWET PERCEPTION AND VANGUARD |
Applicant |
OCUTEC CORPORATION, INC. |
2700-200 GATEWAY CENTER BLVD. |
MORRISVILLE,
NC
27560
|
|
Applicant Contact |
ALAN J TOUCH |
Correspondent |
OCUTEC CORPORATION, INC. |
2700-200 GATEWAY CENTER BLVD. |
MORRISVILLE,
NC
27560
|
|
Correspondent Contact |
ALAN J TOUCH |
Regulation Number | 886.5916
|
Classification Product Code |
|
Date Received | 05/27/1994 |
Decision Date | 08/05/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|