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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 K905183
Device Name NEON RUBBER SUNGLASSES
Applicant
Ha-Lo Advertising Specialties, Inc.
3856 Oakton
Skokie,  IL  60076
Applicant Contact DONNA SMOTHERS
Correspondent
Ha-Lo Advertising Specialties, Inc.
3856 Oakton
Skokie,  IL  60076
Correspondent Contact DONNA SMOTHERS
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received11/19/1990
Decision Date 03/04/1991
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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