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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 K971327
Device Name UNIKA
Applicant
Eyewear Partners Co.
2 Northeast 40th St.
Suite 202
Miami,  FL  33137
Applicant Contact MURRAY LEIBSON
Correspondent
Eyewear Partners Co.
2 Northeast 40th St.
Suite 202
Miami,  FL  33137
Correspondent Contact MURRAY LEIBSON
Regulation Number886.5850
Classification Product Code
HQY  
Date Received04/10/1997
Decision Date 05/09/1997
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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