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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record P010013

Device name not on record · Hologic, Inc. · decided 2010-01-12 (APPR)

FDA 510(k) database ↗

Devices

BrandModelCompanyProduct codesPrimary DI
NovaSureNovaSure ControllerHologic, Inc.MNB15420045500860
NovaSureV5Hologic, Inc.MNB15420045514300
NovaSureNovaSure ControllerHologic, Inc.MNB15420045500853
NovaSureV5Hologic, Inc.MNB15420045514294
NovaSureNS2013USHologic, Inc.MNB15420045501119
815012US815012USHologic, Inc.MNB25420045505398
NovaSureNS2000USHologic, Inc.MNB15420045501140
NovaSure SureSound2007Hologic, Inc.MNB15420045501133
NovaSure SureSound2013Hologic, Inc.MNB15420045501126