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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 K921882
Device Name THE CLEANER ACCESSORY
Applicant
Eaton Medical Corp.
2288 Dunn Ave.
Memphis,  TN  38114
Applicant Contact BRON EATON
Correspondent
Eaton Medical Corp.
2288 Dunn Ave.
Memphis,  TN  38114
Correspondent Contact BRON EATON
Regulation Number886.5928
Classification Product Code
LYL  
Date Received04/21/1992
Decision Date 08/25/1992
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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