FDA 510(k) Application Details - K991958

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

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510(K) Number K991958
Device Name Detectors And Removers, Lice, (Including Combs)
Applicant KIEL LABORATORIES, INC.
2225 CENTENNIAL DR.
GAINESVILLE, GA 30504 US
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Contact TANYJA PORCHA
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Regulation Number 880.5960

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Classification Product Code LJL
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Date Received 06/10/1999
Decision Date 08/13/1999
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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