![]() ![]() Repro-Med Systems, Inc., dba KORU 510(k) NO: K200176(Traditional)ĪTTN: Cynthia Lacatena PHONE NO : 845 4692042Ģ4 Carpenter Road SE DECISION MADE: 15-DEC-21Ĭhester NY 10918 510(k) SUMMARY AVAILABLE FROM FDA Valhalla NY 10595 510(k) SUMMARY AVAILABLE FROM FDAĭEVICE: FREEDOM Integrated Syringe Infusion System Perotti 18 SE DECISION MADE: 27-DEC-21īrescia IT 25125 510(k) SUMMARY AVAILABLE FROM FDAĭEVICE: Contour® next GEN Blood Glucose Monitoring SystemĪscensia Diabetes Care 510(k) NO: K193407(Traditional)ĪTTN: Colleen Burdel PHONE NO : 914 2962880ġ00 Summit Lake Drive SE DECISION MADE: 23-DEC-21 Ithaca NY 14850 510(k) SUMMARY AVAILABLE FROM FDAĬOPAN WASP S.r.l. Rheonix, Inc 510(k) NO: K193081(Traditional)ĪTTN: Richard Montagna PHONE NO : 607 2571242ġ0 Brown Road, Suite 103 SE DECISION MADE: 17-DEC-21 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINALĭECISIONS RENDERED DURING THE PERIOD December 2021ĭEVICE: Rheonix STI Tri-Plex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit, Rheonix Swab Specimen Collection Kit ![]()
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