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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name haploscope
510(k) Number K012530
FOIA Releasable 510(k) K012530
Device Name AA-1 SYSTEM
Applicant
NEUROVISION, INC.
12300 TWINBROOK PKWY.
SUITE 230
ROCKVILLE,  MD  20852
Applicant Contact RICHARD E LIPPMAN
Correspondent
NEUROVISION, INC.
12300 TWINBROOK PKWY.
SUITE 230
ROCKVILLE,  MD  20852
Correspondent Contact RICHARD E LIPPMAN
Regulation Number886.1340
Classification Product Code
HJT  
Date Received08/06/2001
Decision Date 08/31/2001
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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