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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 K973174
Device Name SONIQUE HAIR REMOVER
Applicant
Global TV Concepts, Ltd.
700 Thirteenth St., NW
Washington,  DC  20005
Applicant Contact SAMIA N RODRIGUEZ
Correspondent
Global TV Concepts, Ltd.
700 Thirteenth St., NW
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
Predetermined Change
Control Plan Authorized		 No
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