Device Classification Name |
Perimeter, Automatic, Ac-Powered
|
510(k) Number |
K050350 |
Device Name |
THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) |
Applicant |
NOTAL VISION, INC. |
15825 SHADY GROVE RD., STE 30 |
ROCKVILLE,
MD
20850
|
|
Applicant Contact |
RICHARD E LIPPMAN |
Correspondent |
NOTAL VISION, INC. |
15825 SHADY GROVE RD., STE 30 |
ROCKVILLE,
MD
20850
|
|
Correspondent Contact |
RICHARD E LIPPMAN |
Regulation Number | 886.1605
|
Classification Product Code |
|
Date Received | 02/11/2005 |
Decision Date | 04/29/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|