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510(k) K020592

ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 by Alba-Waldensian, Inc. — Product Code DWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2002
Date Received
February 22, 2002
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

Other clearances by Alba-Waldensian, Inc.

  • K961405 — ALBA HEALTH PAS WRAP SYSTEM (December 26, 1996)
  • K852091 — ALBA DRY BURN PAD (June 13, 1985)
  • K792357 — STERILE IMPERVIOUS ORTHOPEDIC STOCKIN (December 18, 1979)
  • K781964 — COMPRESSION DEVICES, LIMB (December 12, 1978)
  • K780570 — TUBULAR DRESSING RETAINER (April 19, 1978)
  • K780547 — STERILE ORTHOPEDIC STOCKINETTE (April 10, 1978)
  • K771913 — HEEL/ELBOW PROTECTOR (November 15, 1977)

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)