FDA 510(k) Application Details - K132794

Device Classification Name Percussor, Powered-Electric

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510(K) Number K132794
Device Name Percussor, Powered-Electric
Applicant ELECTROMED, INC.
502 SIXTH AVE. N.W.
NEW PRAGUE, MN 56071 US
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Contact CHET SIEVERT
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Regulation Number 868.5665

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Classification Product Code BYI
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Date Received 09/06/2013
Decision Date 12/19/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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