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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Topographer, Corneal, Ac-Powered
510(k) Number K964702
Device Name EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800
Applicant
Euclid Systems Corp.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Applicant Contact ANNE MARIE CESARIO, R.A.C.
Correspondent
Euclid Systems Corp.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Correspondent Contact ANNE MARIE CESARIO, R.A.C.
Regulation Number886.1350
Classification Product Code
MMQ  
Date Received11/25/1996
Decision Date 05/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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