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510(k) K051324

MEDI BUTLER by Medi USA, LP — Product Code DWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2005
Date Received
May 20, 2005
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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  • K941926 — MEDI STRUMPF (June 15, 1994)

Other clearances for product code DWL

  • K141127 — MEDLINE ANTI-EMBOLISM STOCKING (August 21, 2014)
  • K131496 — BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) (July 10, 2013)
  • K122485 — ENCIRCLE COMPRESSION THERAPY STOCKING (April 23, 2013)
  • K123820 — BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EM (April 2, 2013)
  • K123085 — FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOC (December 20, 2012)
  • K123398 — DR. SCHOLL'S COMPRESSION SOCKS (December 18, 2012)
  • K123561 — ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS (December 18, 2012)
  • K121106 — TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION G (April 27, 2012)
  • K112769 — CURAD COMPRESSION HOSIERY (March 1, 2012)
  • K111662 — VENOTRAIN CURAFLOW (October 4, 2011)