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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Lens, Contact (Polymethylmethacrylate)
510(k) Number K860677
Device Name EASY EYES TM LENS CARRYING CASE
Applicant
Applied Laboratories, Inc.
3360 Commerce Park Dr.
Columbus,  IN  47201
Applicant Contact ANTHONY J MORAVEC
Correspondent
Applied Laboratories, Inc.
3360 Commerce Park Dr.
Columbus,  IN  47201
Correspondent Contact ANTHONY J MORAVEC
Classification Product Code
HPX  
Date Received02/25/1986
Decision Date 05/29/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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