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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number886.1605
Classification Product Code
HPT  
Date Received02/11/2005
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
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