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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
Applicant
SURGICAL APPLIANCE INDUSTRIES, INC.
3960 rosslyn dr.
cincinnati,  OH  45209
Applicant Contact gary parsons
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 pfingsten rd.
northbrook,  IL  60062
Correspondent Contact ned devine
Regulation Number880.5780
Classification Product Code
DWL  
Date Received04/12/2012
Decision Date 04/27/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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