FDA 510(k) Application Details - K112874

Device Classification Name Tourniquet, Pneumatic

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510(K) Number K112874
Device Name Tourniquet, Pneumatic
Applicant DOMINION MEDICAL DEVICES, LLC
P.O. BOX 560
STILLWATER, MN 55082 US
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Contact ELAINE DUNCAN
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Regulation Number 878.5910

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Classification Product Code KCY
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Date Received 09/30/2011
Decision Date 10/17/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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