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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stocking, medical support (to prevent pooling of blood in legs)
510(k) Number K121106
Device Name TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET
Original Applicant
SURGICAL APPLIANCE INDUSTRIES, INC.
3960 rosslyn dr.
cincinnati,  OH  45209
Original Contact gary parsons
Regulation Number880.5780
Classification Product Code
DWL  
Date Received04/12/2012
Decision Date 04/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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