FDA 510(k) Application Details - K172481

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

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510(K) Number K172481
Device Name Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant Dornoch Medical Systems
200 North West Parkway
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 08/16/2017
Decision Date 09/14/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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