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510(k) K040936

PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE by Leda Co., Ltd. — Product Code FQM

K040936 is an FDA 510(k) premarket notification submitted by Leda Co., Ltd. for the device "PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE". The FDA issued a decision of Substantially Equivalent on May 3, 2004. The device falls under product code FQM (Bandage, Elastic), a Class I device regulated under 21 CFR 880.5075.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2004
Date Received
April 9, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Elastic
Device Class
Class I
Regulation Number
880.5075
Review Panel
HO
Submission Type

Other clearances for product code FQM

  • K040054 — BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND A (April 27, 2004)
  • K013244 — COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCA (December 7, 2001)
  • K952738 — SKIN SAVER SYSTEMS (September 29, 1995)
  • K872868 — ASPEN ESMARK BANDAGE (July 31, 1987)
  • K840107 — TUBE-BANDAGE FOR HUMAN DIGITS 200 (April 25, 1984)
  • K831728 — MEDICALEX (January 9, 1984)
  • K830622 — ORTHO WRAP (June 20, 1983)
  • K831551 — COMPRESSOGRIP TUBULAR ELASTIC BANDAGE (June 7, 1983)
  • K820142 — TUBULAR STOCKINETTE (February 5, 1982)
  • K820141 — BIAS STOCKINETTE (February 5, 1982)

FDA data resources