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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 K945123
Device Name ARISTAR EYEWEAR, ESPRIT EYEWEAR
Applicant
Aristar Inc. U.S.A.
402 American Rd.
Morris Plains,  NJ  07950
Applicant Contact MIKE OTANI
Correspondent
Aristar Inc. U.S.A.
402 American Rd.
Morris Plains,  NJ  07950
Correspondent Contact MIKE OTANI
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received10/19/1994
Decision Date 11/22/1994
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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