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FDA 510(k), K112827, SHEATHES ULTRASOND GEL
FDA 510(k), K112827, SHEATHES ULTRASOND GEL
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510(K) Number: K112827
Device Name: SHEATHES ULTRASOND GEL
Manufacturer: JENNIFER DOWNING
Device Classification Name: Media, Coupling, Ultrasound
Regulation Number: MUI
Classification Product Code: 09/28/2011
Date Received: 06/22/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: SHEATHES ULTRASOND GEL
Manufacturer: JENNIFER DOWNING
Device Classification Name: Media, Coupling, Ultrasound
Regulation Number: MUI
Classification Product Code: 09/28/2011
Date Received: 06/22/2012
Decision Date: Substantially Equivalent (SESE)
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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