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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 K943202
Device Name EASSUN HI-TECH OPTICS
Applicant
Ultimate Concepts, Inc.
2761 Ocean Club Blvd. #106
Hollywood,  FL  33019
Applicant Contact ANDREA S CROSS
Correspondent
Ultimate Concepts, Inc.
2761 Ocean Club Blvd. #106
Hollywood,  FL  33019
Correspondent Contact ANDREA S CROSS
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/05/1994
Decision Date 07/27/1994
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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