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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name media,coupling,ultrasound
510(k) Number K112827
Device Name SHEATHES ULTRASOND GEL
Original Applicant
SHEATHING TECHNOLOGIES, INC.
18431 technology dr.
morgan hill,  CA  95037
Original Contact jennifer downing
Regulation Number892.1570
Classification Product Code
MUI  
Date Received09/28/2011
Decision Date 06/22/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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