FDA 510(k) Application Details - K123188

Device Classification Name Apparatus, Suction, Ward Use, Portable, Ac-Powered

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510(K) Number K123188
Device Name Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant DORNOCH MEDICAL SYSTEMS, INC.
200 Nw Parkway Rd
RIVERSIDE, MO 64150 US
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Contact LARRY SMITH
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Regulation Number 878.4780

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Classification Product Code JCX
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Date Received 10/11/2012
Decision Date 03/04/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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