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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 K942845
Device Name PERSOL, MOSCLHINO, AND GERALD GENTA
Applicant
Persol America, Inc.
6501 Park Of Commerce Blvd.,
Suite 110
Boca Raton,  FL  33487
Applicant Contact JAIME GODDUR
Correspondent
Persol America, Inc.
6501 Park Of Commerce Blvd.,
Suite 110
Boca Raton,  FL  33487
Correspondent Contact JAIME GODDUR
Regulation Number886.5842
Classification Product Code
HQZ  
Subsequent Product Code
HQY  
Date Received06/16/1994
Decision Date 08/04/1994
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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