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510(k) K101614

HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 by Dm Systems, Incorporated — Product Code DWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2011
Date Received
June 9, 2010
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

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  • K112769 — CURAD COMPRESSION HOSIERY (March 1, 2012)
  • K111662 — VENOTRAIN CURAFLOW (October 4, 2011)