Device Classification Name |
Lens, Spectacle, Non-Custom (Prescription)
|
510(k) Number |
K863367 |
Device Name |
FORMALENS 2000 |
Applicant |
VISION-SCIENCES, INC. |
140 EAST DUARTE RD. |
MONROVIA,
CA
91016
|
|
Applicant Contact |
HOWARD SILVERMAN |
Correspondent |
VISION-SCIENCES, INC. |
140 EAST DUARTE RD. |
MONROVIA,
CA
91016
|
|
Correspondent Contact |
HOWARD SILVERMAN |
Regulation Number | 886.5844
|
Classification Product Code |
|
Date Received | 09/03/1986 |
Decision Date | 09/26/1986 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|