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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 K935729
Device Name OPTICAL FRAMES AND/OR SUNGLASSES
Applicant
Ivo Eyewear, Inc.
P.O. Box 490233
Miami,  FL  33149
Applicant Contact JACQUELINE ALLER
Correspondent
Ivo Eyewear, Inc.
P.O. Box 490233
Miami,  FL  33149
Correspondent Contact JACQUELINE ALLER
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received12/01/1993
Decision Date 02/16/1994
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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