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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 K915845
Device Name HAIR TRONICS MODEL HT8000
Applicant
Global Tronics Intl., Inc.
2626 Lavery Ct., Suite 301
Newbury Park,  CA  91320
Applicant Contact MANTELL, JR.
Correspondent
Global Tronics Intl., Inc.
2626 Lavery Ct., Suite 301
Newbury Park,  CA  91320
Correspondent Contact MANTELL, JR.
Regulation Number878.5360
Classification Product Code
KCX  
Date Received12/26/1991
Decision Date 07/29/1992
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
Predetermined Change
Control Plan Authorized		 No
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