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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Refractometer, Ophthalmic
510(k) Number K843042
Device Name VISION TESTER
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 Number886.1760
Classification Product Code
HKO  
Date Received08/02/1984
Decision Date 10/05/1984
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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