FDA 510(k) Application Details - K083206

Device Classification Name Detectors And Removers, Lice, (Including Combs)

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510(K) Number K083206
Device Name Detectors And Removers, Lice, (Including Combs)
Applicant LARADA SCIENCES
148 S. 1200 E.
SALT LAKE CITY, UT 84102-1643 US
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Contact PHIL TRIOLO
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Regulation Number 880.5960

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Classification Product Code LJL
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Date Received 10/31/2008
Decision Date 03/10/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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