FDA 510(k) Application Details - K981250

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

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510(K) Number K981250
Device Name Detectors And Removers, Lice, (Including Combs)
Applicant NATIONAL PEDICULOSIS ASSOC.
50 KEARNEY RD.
NEEDHAM, MA 02494 US
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Contact HANS SCHWARTZ
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Regulation Number 880.5960

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Classification Product Code LJL
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Date Received 04/06/1998
Decision Date 05/28/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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