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@qmsnews.bsky.socialOct 1, 2026, 5:04 AM

Every 510(k) clearance is a quiet receipt for a company's design controls. CraniUS, LLC just cashed one for the CraniUS Plate. #FDA #510k #MedDevice
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K262874
accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pm…

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