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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 K851062
Device Name DERAPAGE EYEWEAR BY VITALONI
Applicant
Vitaloni S.P.A.
Patton, Boggs & Blow
2550 M St. NW
Washington,  DC  20037
Applicant Contact DEBORAH F NEIPRIS
Correspondent
Vitaloni S.P.A.
Patton, Boggs & Blow
2550 M St. NW
Washington,  DC  20037
Correspondent Contact DEBORAH F NEIPRIS
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/15/1985
Decision Date 04/01/1985
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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