FDA 510(k) Application Details - K981147

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

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510(K) Number K981147
Device Name Detectors And Removers, Lice, (Including Combs)
Applicant CARE TECHNOLOGIES, INC.
2000 M ST. NW (#700)
WASHINGTON, DC 20036 US
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Contact DANIEL J MANELLI
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Regulation Number 880.5960

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Classification Product Code LJL
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Date Received 03/30/1998
Decision Date 06/09/1998
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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