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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 K940977
Device Name SPECTACLE FRAMES
Applicant
Super Optical, Inc.
3805 W. 16th Ave.
Hialeah,  FL  33012
Applicant Contact JUAN E . LOPEZ
Correspondent
Super Optical, Inc.
3805 W. 16th Ave.
Hialeah,  FL  33012
Correspondent Contact JUAN E . LOPEZ
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received03/01/1994
Decision Date 04/29/1994
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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