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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, Needle-Type
510(k) Number K952611
Device Name STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION
Applicant
Sterex Electrolysis Intl., Ltd.
174 Kings Rd.
Tyseley
Birmingham,  GB B11 2AP
Correspondent
Sterex Electrolysis Intl., Ltd.
174 Kings Rd.
Tyseley
Birmingham,  GB B11 2AP
Regulation Number878.5350
Classification Product Code
KCW  
Date Received06/07/1995
Decision Date 10/18/1995
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
Predetermined Change
Control Plan Authorized		 No
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