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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 K923500
Device Name BEAUSOLEIL FRAME
Applicant
Oliver Peoples, Inc.
8600 Sunset Blvd.
Los Angeles,  CA  90069
Applicant Contact JONATHAN FIELDS
Correspondent
Oliver Peoples, Inc.
8600 Sunset Blvd.
Los Angeles,  CA  90069
Correspondent Contact JONATHAN FIELDS
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received07/15/1992
Decision Date 02/16/1993
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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