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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 K940324
Device Name SPECTACLE SUN GLASSES
Applicant
Occhiali, International Eyewear
7220 NW 36th St. N. 301
Miami,  FL  33166
Applicant Contact FORTUNATO FARACHE
Correspondent
Occhiali, International Eyewear
7220 NW 36th St. N. 301
Miami,  FL  33166
Correspondent Contact FORTUNATO FARACHE
Regulation Number886.5850
Classification Product Code
HQY  
Date Received01/24/1994
Decision Date 05/26/1995
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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