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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 K933956
Device Name ALDO'S OPTICAL FRAME COLLECTION
Applicant
Frontier Novelty, Inc.
903 Lincoln St.
P.O.Box 147
Laredo,  TX  78040
Applicant Contact ALDO TATANGELO JR.
Correspondent
Frontier Novelty, Inc.
903 Lincoln St.
P.O.Box 147
Laredo,  TX  78040
Correspondent Contact ALDO TATANGELO JR.
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received08/12/1993
Decision Date 10/18/1993
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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