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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 K083206
Device Name LOUSEBUSTER
Applicant
Larada Sciences
148 S. 1200 E.
Salt Lake City,  UT  84102
Applicant Contact PHIL TRIOLO
Correspondent
Larada Sciences
148 S. 1200 E.
Salt Lake City,  UT  84102
Correspondent Contact PHIL TRIOLO
Regulation Number880.5960
Classification Product Code
LJL  
Date Received10/31/2008
Decision Date 03/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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