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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 K941148
Device Name SUNGLASSES
Applicant
Metal Dream S.R.L.
Loc. Campopiano, 11
32040 Vigo Di Cadore
(Bl)- Italy,  IT
Applicant Contact DA PRA MARIO
Correspondent
Metal Dream S.R.L.
Loc. Campopiano, 11
32040 Vigo Di Cadore
(Bl)- Italy,  IT
Correspondent Contact DA PRA MARIO
Regulation Number886.5850
Classification Product Code
HQY  
Subsequent Product Code
HQZ  
Date Received03/10/1994
Decision Date 08/04/1994
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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