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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biomicroscope, slit-lamp, ac-powered
510(k) Number K862379
Device Name CORNEAL MODELING SYSTEM
Applicant
COMPUTED ANATOMY, INC.
310 EAST 14TH ST.
ROOM 232 SOUTH
NEW YORK,  NY  10003
Applicant Contact MARTIN GERSTEN
Correspondent
COMPUTED ANATOMY, INC.
310 EAST 14TH ST.
ROOM 232 SOUTH
NEW YORK,  NY  10003
Correspondent Contact MARTIN GERSTEN
Regulation Number886.1850
Classification Product Code
HJO  
Date Received06/24/1986
Decision Date 08/25/1986
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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