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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, tweezer-type
510(k) Number K770791
Device Name DEPILATOR, DERMA-I & DERMA-II
Applicant
ELECTRO-KINETIC ENG/MFG
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ELECTRO-KINETIC ENG/MFG
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.5360
Classification Product Code
KCX  
Date Received05/02/1977
Decision Date 01/26/1981
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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