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FDA 510(k), K163328, Planmed Clarity
FDA 510(k), K163328, Planmed Clarity
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510(K) Number: K163328
Device Name: Planmed Clarity
Manufacturer: Lars Moring
Device Classification Name: Full Field Digital, System, X-Ray, Mammographic
Regulation Number: MUE
Classification Product Code: KXA
Date Received: 11/28/2016
Decision Date: 12/28/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: Planmed Clarity
Manufacturer: Lars Moring
Device Classification Name: Full Field Digital, System, X-Ray, Mammographic
Regulation Number: MUE
Classification Product Code: KXA
Date Received: 11/28/2016
Decision Date: 12/28/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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