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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 K943872
Device Name COMMANDER MARK II HAIR REMOVAL SYSTEM
Applicant
THE HELENE EDGAR CORP.
3-304 STONE RD. WEST, #326
GUELPH, ONTARIO,  CA N1G 4W4
Applicant Contact KEITH EDGAR
Correspondent
THE HELENE EDGAR CORP.
3-304 STONE RD. WEST, #326
GUELPH, ONTARIO,  CA N1G 4W4
Correspondent Contact KEITH EDGAR
Regulation Number878.5360
Classification Product Code
KCX  
Date Received08/08/1994
Decision Date 10/26/1995
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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