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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K010315
FOIA Releasable 510(k) K010315
Device Name ISCREEN VISION SCREENER
Applicant
Iscreen, LLC
668 Colonial Rd. (Suite 1)
Memphis,  TN  38117
Applicant Contact PETER THRALL
Correspondent
Iscreen, LLC
668 Colonial Rd. (Suite 1)
Memphis,  TN  38117
Correspondent Contact PETER THRALL
Regulation Number886.1120
Classification Product Code
HKI  
Date Received02/02/2001
Decision Date 06/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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