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Maxxon, Globe Med Tech complete final design of ReVax Safety Syringe
By Lisa Kerner
Charlotte, N.C., June 15 - Maxxon, Inc. said results of Globe Med Tech's user/lab study has resulted in the final design of the Maxxon 3cc Vacuum Operated Retractable Safety Syringe (ReVac) plunger.
Globe Med Tech has manufactured the 5,000 piece sample for application to the Food and Drug Administration and customer evaluation prior to seeking FDA 510k registration, according to a company news release.
All biocompatibility and clinical testing of the samples is expected to be completed in two to three months.
"It may seem like a small step, but it's actually a giant move forward for us, due to the significance of clinical test for FDA registration, which is why product development takes years to accomplish from patent concept to real functional sample that meet design, FDA and marketing criteria," Maxxon chief technology officer Andy Hu said in the release.
Located in Mount Pleasant, S.C., Maxxon produces safety-engineered medical devices including the ReVac Safety Syringe, Auto Retractable Safety Scalpel with Permanent Lock and the Auto Retractable Safety IV Catheter.
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