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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 K930585
Device Name SUNGLASSES
Applicant
Daiko S.R.L.
Via Solferino, 21
Zona Artiganale Via Teze
Cavriana (Mantova),  IT 46040
Applicant Contact ANNA DALZINI
Correspondent
Daiko S.R.L.
Via Solferino, 21
Zona Artiganale Via Teze
Cavriana (Mantova),  IT 46040
Correspondent Contact ANNA DALZINI
Regulation Number886.5850
Classification Product Code
HQY  
Date Received02/04/1993
Decision Date 11/12/1993
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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