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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Ac-Powered
510(k) Number K871335
Device Name TOPCON COMPUTERIZED TONOMETER CT-10
Applicant
Topcon Instrument Corporation of America
65 W. Century Rd.
Paramus,  NJ  07652
Applicant Contact GORDON W SITEMAN
Correspondent
Topcon Instrument Corporation of America
65 W. Century Rd.
Paramus,  NJ  07652
Correspondent Contact GORDON W SITEMAN
Regulation Number886.1930
Classification Product Code
HKX  
Date Received04/03/1987
Decision Date 05/18/1987
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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