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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 K944207
Device Name TOPOGRAPHIC MODELING SYSTEM 2 TMS-2
Applicant
Computed Anatomy, Inc.
28 W. 36th St.
New York,  NY  10018
Applicant Contact CHARLES J KLEIN
Correspondent
Computed Anatomy, Inc.
28 W. 36th St.
New York,  NY  10018
Correspondent Contact CHARLES J KLEIN
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received08/29/1994
Decision Date 12/07/1994
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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