FDA 510(k) Application Details - K173603

Device Classification Name Percussor, Powered-Electric

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510(K) Number K173603
Device Name Percussor, Powered-Electric
Applicant Hill-Rom Holdings, Inc.
1 Yishun Ave 7
Singapore SG
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Contact Joseph Braido
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Regulation Number 868.5665

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Classification Product Code BYI
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Date Received 11/21/2017
Decision Date 10/24/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K173603


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