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FDA 510(k), K163050, Advance Medical Designs, Inc. Sterile Ultrasound Gel
FDA 510(k), K163050, Advance Medical Designs, Inc. Sterile Ultrasound Gel
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510(K) Number: K163050
Device Name: Advance Medical Designs, Inc. Sterile Ultrasound Gel
Manufacturer: ADVANCE MEDICAL DESIGNS, INC.
Device Classification Name: Media, Coupling, Ultrasound
Regulation Number: 892.1570
Classification Product Code: MUI
Date Received: 11/01/2016
Decision Date: 10/25/2017
Regulation Medical Specialty: Radiology
Device Name: Advance Medical Designs, Inc. Sterile Ultrasound Gel
Manufacturer: ADVANCE MEDICAL DESIGNS, INC.
Device Classification Name: Media, Coupling, Ultrasound
Regulation Number: 892.1570
Classification Product Code: MUI
Date Received: 11/01/2016
Decision Date: 10/25/2017
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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