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510(k) K131496

BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) by Bsn Medical, Inc. — Product Code DWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2013
Date Received
May 23, 2013
Clearance Type
Special
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 Bsn Medical, Inc.

  • K143151 — Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hy (January 26, 2015)
  • K123561 — ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS (December 18, 2012)

Other clearances for product code DWL

  • K141127 — MEDLINE ANTI-EMBOLISM STOCKING (August 21, 2014)
  • 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)
  • K123561 — ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS (December 18, 2012)
  • K123398 — DR. SCHOLL'S COMPRESSION SOCKS (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)
  • K101614 — HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 (January 13, 2011)