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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 K952597
Device Name VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW
Applicant
Point of View Optical Outlet, Inc.
18757 Biscayne Blvd.
Aventura,  FL  33180
Applicant Contact JACKY AMAR
Correspondent
Point of View Optical Outlet, Inc.
18757 Biscayne Blvd.
Aventura,  FL  33180
Correspondent Contact JACKY AMAR
Regulation Number886.5842
Classification Product Code
HQZ  
Subsequent Product Code
HQY  
Date Received06/06/1995
Decision Date 09/12/1995
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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