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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detectors And Removers, Lice, (Including Combs)
510(k) Number K930859
Device Name ROBI COMBI
Applicant
Epilady 2000, LLC
1333 New Hampshire Ave.,NW
Suite 400
Washington D.C.,  DC  20036
Applicant Contact DONALD E SEGAL
Correspondent
Epilady 2000, LLC
1333 New Hampshire Ave.,NW
Suite 400
Washington D.C.,  DC  20036
Correspondent Contact DONALD E SEGAL
Regulation Number880.5960
Classification Product Code
LJL  
Date Received02/18/1993
Decision Date 02/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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