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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 K882308
Device Name CR-39 PLASTIC LENSES FOR EYEGLASSES
Applicant
Automated Lens System
6376 SW 10 Ter.
Miami,  FL  33144
Applicant Contact MICHAEL WALACH
Correspondent
Automated Lens System
6376 SW 10 Ter.
Miami,  FL  33144
Correspondent Contact MICHAEL WALACH
Regulation Number886.5844
Classification Product Code
HQG  
Date Received06/03/1988
Decision Date 07/22/1988
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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