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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: KXA
Date Received: 09/28/2011
Decision Date: 06/22/2012
Decision: 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: KXA
Date Received: 09/28/2011
Decision Date: 06/22/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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