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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 K935706
Device Name EPI 2
Applicant
Universal H.R. System, Inc.
4601 W. Kennedy Blvd.,
Suite 107
Tampa,  FL  33609
Applicant Contact WILLIAM H SIMPSON
Correspondent
Universal H.R. System, Inc.
4601 W. Kennedy Blvd.,
Suite 107
Tampa,  FL  33609
Correspondent Contact WILLIAM H SIMPSON
Regulation Number878.5360
Classification Product Code
KCX  
Date Received11/30/1993
Decision Date 02/11/1997
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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