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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 K951979
Device Name SUNGLASSES
Applicant
Heyro Optical Manufactory
20 N. Wacker Dr.
Suite 1416
Chicago,  IL  60606
Applicant Contact JOAN BAUMGARTNER
Correspondent
Heyro Optical Manufactory
20 N. Wacker Dr.
Suite 1416
Chicago,  IL  60606
Correspondent Contact JOAN BAUMGARTNER
Regulation Number886.5850
Classification Product Code
HQY  
Date Received04/27/1995
Decision Date 07/17/1995
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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