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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Spectacle, Non-Custom (Prescription)
510(k) Number K881225
Device Name OPHTHALMIC SPECTACLE LENS BLANKS
Applicant
Beta Optical Co, Inc.
7041 SW 21 Pl.
Davie,  FL  33317
Applicant Contact JAMES MAGALHAES
Correspondent
Beta Optical Co, Inc.
7041 SW 21 Pl.
Davie,  FL  33317
Correspondent Contact JAMES MAGALHAES
Regulation Number886.5844
Classification Product Code
HQG  
Date Received03/22/1988
Decision Date 04/19/1988
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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