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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lens, contact, polymethylmethacrylate, diagnostic
510(k) Number K862094
Device Name LENS-EZE
Applicant
INSIGHT INTERNATIONAL, INC.
4887 CLARK LAKEWAY
ACWORTH,  GA  30101
Applicant Contact DAVID H KOLACK
Correspondent
INSIGHT INTERNATIONAL, INC.
4887 CLARK LAKEWAY
ACWORTH,  GA  30101
Correspondent Contact DAVID H KOLACK
Regulation Number886.1385
Classification Product Code
HJK  
Date Received06/02/1986
Decision Date 06/19/1986
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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