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LessIsMore

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Monday, 11/06/2023 11:50:05 AM

Monday, November 06, 2023 11:50:05 AM

Post# of 461
KRMD receives US FDA 510(k) approval for the Freedom60 Infusion System. Press release is imminent.
This is a low-volume trading stock so please be careful. In addition earnings release scheduled for after-market on Wednesday.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231918


Device Classification Name pump, infusion
510(k) Number K231918
Device Name Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter
Applicant
Koru Medical Systems
100 Corporate Dr
Mahwah, NJ 07430
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