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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name keratoscope, ac-powered
510(k) Number K902012
Device Name VKS-1 VIDEO KERATOSCOPE
Applicant
COMPUTED ANATOMY, INC.
28 WEST 36TH ST.
NEW YORK,  NY  10018
Applicant Contact MARTIN GERSTEN
Correspondent
COMPUTED ANATOMY, INC.
28 WEST 36TH ST.
NEW YORK,  NY  10018
Correspondent Contact MARTIN GERSTEN
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received05/03/1990
Decision Date 06/22/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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