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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ophthalmic
510(k) Number K903421
Device Name TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASER
Applicant
TOP CON
65 WEST CENTURY RD.
PARAMUS,  NJ  07652
Applicant Contact PETER LEADEM
Correspondent
TOP CON
65 WEST CENTURY RD.
PARAMUS,  NJ  07652
Correspondent Contact PETER LEADEM
Regulation Number886.4390
Classification Product Code
HQF  
Date Received07/31/1990
Decision Date 12/18/1990
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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