510(k) K091141

THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS by Knit-Rite, Inc. — Product Code DWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2009
Date Received
April 20, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Device Class
Class II
Regulation Number
880.5780
Review Panel
HO
Submission Type