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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Grid, Amsler
510(k) Number K014044
Device Name MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)
Applicant
NOTAL VISION, INC.
12300 TWINBROOK PKWAY; STE 625
ROCKVILLE,  MD  20852
Applicant Contact RICHARD E LIPPMAN
Correspondent
NOTAL VISION, INC.
12300 TWINBROOK PKWAY; STE 625
ROCKVILLE,  MD  20852
Correspondent Contact RICHARD E LIPPMAN
Regulation Number886.1330
Classification Product Code
HOQ  
Date Received12/07/2001
Decision Date 03/04/2002
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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