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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 K851698
Device Name ANNE MARIE PERRIS SUNGLASSES AND FRAMES
Applicant
Perlinea Co.
Via Cavour 84
Ravenna, Italy,  IT 48100
Applicant Contact MARIE PERRIS
Correspondent
Perlinea Co.
Via Cavour 84
Ravenna, Italy,  IT 48100
Correspondent Contact MARIE PERRIS
Regulation Number886.5850
Classification Product Code
HQY  
Date Received04/24/1985
Decision Date 07/31/1985
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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