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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 K945382
Device Name TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER
Applicant
EXPERTECH ASSOC., INC.
100 MAIN ST.
SUITE 120
CONCORD,  MA  01742
Applicant Contact DAVID M LINK
Correspondent
EXPERTECH ASSOC., INC.
100 MAIN ST.
SUITE 120
CONCORD,  MA  01742
Correspondent Contact DAVID M LINK
Regulation Number886.1350
Classification Product Code
HLQ  
Date Received11/02/1994
Decision Date 01/31/1995
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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