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510(k) K790210

STOCKINETTE, TUBULAR UNBLEACHED by The Owenby Co. — Product Code FQM

K790210 is an FDA 510(k) premarket notification submitted by The Owenby Co. for the device "STOCKINETTE, TUBULAR UNBLEACHED". The FDA issued a decision of Substantially Equivalent on February 27, 1979. The device falls under product code FQM (Bandage, Elastic), a Class I device regulated under 21 CFR 880.5075. The Owenby Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1979
Date Received
January 30, 1979
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 by The Owenby Co.

  • K801628 — RESTRAINT, PROTECTIVE (August 7, 1980)
  • K801626 — ARM SLING (July 28, 1980)
  • K801532 — STOCKINETTE, STERILE TWO PLY W/PULL TABS (July 28, 1980)
  • K801627 — COVER, LIMB (July 28, 1980)
  • K801531 — ARM SLING (July 21, 1980)
  • K780764 — NON-STERILE FOLDED GAUZE (June 6, 1978)
  • K780418 — BURN DRESSING PAD (April 10, 1978)
  • K770889 — BURN DRESSING KIT (July 11, 1977)
  • K761069 — P.S.M. BOTIQUE CAP (December 30, 1976)
  • K761070 — P.S.M. SURGICAL HOOD (December 30, 1976)

Other clearances for product code FQM

  • K040936 — PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE (May 3, 2004)
  • 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)

FDA data resources