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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K933189
Device Name SPECTACLE FRAMES AND SUNGLASSES
Applicant
Eastern Breeze Intl. Co.
5001 Collins Ave.
# 14-E
Miami,  FL  33140
Applicant Contact DANIEL BARSU
Correspondent
Eastern Breeze Intl. Co.
5001 Collins Ave.
# 14-E
Miami,  FL  33140
Correspondent Contact DANIEL BARSU
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/30/1993
Decision Date 01/25/1994
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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