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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 K941059
Device Name FRONTIER NOVELTY DAELIM OPTICAL FRAME
Applicant
Frontier Novelty, Inc.
P.O. Box 147
Laredo,  TX  78040
Applicant Contact ALDO TATANGELO, JR.
Correspondent
Frontier Novelty, Inc.
P.O. Box 147
Laredo,  TX  78040
Correspondent Contact ALDO TATANGELO, JR.
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received03/08/1994
Decision Date 04/12/1994
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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