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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 K901363
Device Name TOPOGRAPHIC MODELING SYSTEM
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 Received03/23/1990
Decision Date 05/25/1990
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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