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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Fundus, Hruby, Diagnostic
510(k) Number K902138
Device Name STRIPE PROJECTOR
Applicant
Academic Catalyst Corp.
14 Madison Ave.
Valhalla,  NY  10595
Applicant Contact LAWRENCE KUNSTADT
Correspondent
Academic Catalyst Corp.
14 Madison Ave.
Valhalla,  NY  10595
Correspondent Contact LAWRENCE KUNSTADT
Regulation Number886.1395
Classification Product Code
HJI  
Date Received05/10/1990
Decision Date 07/05/1990
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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