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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Spectacle, Non-Custom (Prescription)
510(k) Number K865103
Device Name KROM-X LENS SYSTEM
Applicant
Neo Optics, Inc.
636 E. Colorado Ave.
Glendale,  CA  91205
Applicant Contact HENRY SCHUMER
Correspondent
Neo Optics, Inc.
636 E. Colorado Ave.
Glendale,  CA  91205
Correspondent Contact HENRY SCHUMER
Regulation Number886.5844
Classification Product Code
HQG  
Date Received12/30/1986
Decision Date 01/20/1987
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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