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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chart, Visual Acuity
510(k) Number K863509
Device Name OPTEC 1000 DMV
Applicant
Stereo Optical Co., Inc.
3539 N. Kenton
Chicago,  IL  60641
Applicant Contact JOSEPH ANDERA
Correspondent
Stereo Optical Co., Inc.
3539 N. Kenton
Chicago,  IL  60641
Correspondent Contact JOSEPH ANDERA
Regulation Number886.1150
Classification Product Code
HOX  
Date Received09/09/1986
Decision Date 11/10/1986
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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