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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burr, Corneal, Battery-Powered
510(k) Number K962989
Device Name AMOILS EPITHELIAL SCRUBBER
Applicant
S. Percy Amoils
333 W. Wacker Dr.
Suite 2600
Chicago,  IL  60606
Applicant Contact RICHARD O WOOD, ESQ.
Correspondent
S. Percy Amoils
333 W. Wacker Dr.
Suite 2600
Chicago,  IL  60606
Correspondent Contact RICHARD O WOOD, ESQ.
Regulation Number886.4070
Classification Product Code
HOG  
Date Received08/01/1996
Decision Date 01/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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