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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 K935764
Device Name NON-PRESCRIPTION SUNGLASSES
Applicant
Airess, Inc.
7070 NW 50th St.
Miami,  FL  33166
Applicant Contact BOBY REGE
Correspondent
Airess, Inc.
7070 NW 50th St.
Miami,  FL  33166
Correspondent Contact BOBY REGE
Regulation Number886.5850
Classification Product Code
HQY  
Date Received09/10/1993
Decision Date 02/22/1994
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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