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FDA 510(k) Applications Submitted by Chris Hughes
FDA 510(k) Number
Submission Date
Device Name
Applicant
K152267
08/11/2015
Remedy« Shoulder Spacer
Osteoremedies LLC
K183017
10/31/2018
Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer
Osteoremedies LLC
K173967
12/29/2017
Remedy Acetabular Cup
Osteoremedies LLC
K161495
06/01/2016
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
LUMINEX CORPORATION
K162772
10/03/2016
ARIES GBS Assay
LUMINEX CORPORATION
K133302
10/25/2013
FLEXMAP 3D
LUMINEX CORP.
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