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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 K973179
Device Name FEMINIQUE SONIC HAIR REMOVER
Applicant
GLOBAL TV CONCEPTS, LTD.
700 THIRTEENTH ST., N.W.
WASHINGTON,  DC  20005
Applicant Contact SAMIA N RODRIGUEZ
Correspondent
GLOBAL TV CONCEPTS, LTD.
700 THIRTEENTH ST., N.W.
WASHINGTON,  DC  20005
Correspondent Contact SAMIA N RODRIGUEZ
Regulation Number878.5360
Classification Product Code
KCX  
Date Received08/25/1997
Decision Date 10/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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