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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K931972
Device Name FRAME - SPECTACLE
Applicant
Eyetel Optics, Inc.
14301 SW 119 Ave.
Miami,  FL  33186
Applicant Contact FRANCES KLISIEWECZ
Correspondent
Eyetel Optics, Inc.
14301 SW 119 Ave.
Miami,  FL  33186
Correspondent Contact FRANCES KLISIEWECZ
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received04/22/1993
Decision Date 10/01/1993
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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