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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 K935954
Device Name OPTICAL FRAME COLLECTION NO. 2
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 Received12/13/1993
Decision Date 02/16/1994
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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