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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Accessories, Solution, Ultrasonic Cleaners For Lenses
510(k) Number K904824
Device Name EASY EYES TM CONTACT LENS CLEANING MACHINE
Applicant
Eaton Medical Corp.
2288 Dunn Ave.
Memphis,  TN  38114
Applicant Contact ELLIS M WHITE
Correspondent
Eaton Medical Corp.
2288 Dunn Ave.
Memphis,  TN  38114
Correspondent Contact ELLIS M WHITE
Regulation Number886.5928
Classification Product Code
LYL  
Date Received10/25/1990
Decision Date 07/05/1991
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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