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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name epilator, high frequency, needle-type
510(k) Number K834572
Device Name EPITRON SUPER
Applicant
LEO UNLIMITED, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
LEO UNLIMITED, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.5350
Classification Product Code
KCW  
Date Received12/29/1983
Decision Date 04/23/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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