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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K870179
Device Name SPECTACLE FRAMES VARIOUS COLORS AND DESIGNS
Applicant
Polinelli
21020 Galliate Lombardo
(Va) Italy
Via Belvedere, 18,  IT
Applicant Contact RICCARDO POLINELLI
Correspondent
Polinelli
21020 Galliate Lombardo
(Va) Italy
Via Belvedere, 18,  IT
Correspondent Contact RICCARDO POLINELLI
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received01/15/1987
Decision Date 04/22/1987
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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