FDA 510(k) Application Details - K173018

Device Classification Name System, X-Ray, Mobile

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510(K) Number K173018
Device Name System, X-Ray, Mobile
Applicant Del Medical, Inc.
241 Covington Dr.
Bloomingdale, IL 60108 US
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Contact Tony Bavuso
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Regulation Number 892.1720

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Classification Product Code IZL
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Date Received 09/28/2017
Decision Date 11/20/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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