FDA 510(k) Application Details - K173101

Device Classification Name System, Image Processing, Radiological

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510(K) Number K173101
Device Name System, Image Processing, Radiological
Applicant Curve Dental LTD
Suite 240, 2912 Memorial Dr. SE
Calgary T2A6R1 CA
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Contact Raul Nemes
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 09/29/2017
Decision Date 10/18/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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