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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 K943753
Device Name FRAME SPECTACLE
Applicant
Optic Tech Corp.
5605 NW 74th Ave.
Miami,  FL  33166
Applicant Contact AGUEDA M GRAUPERA
Correspondent
Optic Tech Corp.
5605 NW 74th Ave.
Miami,  FL  33166
Correspondent Contact AGUEDA M GRAUPERA
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received08/02/1994
Decision Date 09/02/1994
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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