T.E.D. Sequential Compression Sleeves

• • Terminated Z-1041-2019 FDA Class II ·initiated 15 Feb 2019

  The product does not meet sterility requirements. Product labeled as sterile was distributed without undergoing sterilization prior to distribution.

510(k) Number

K781357 ↗

FDA Product Code

JOW

Device Class

Class II

Regulation

21 CFR Part 870.5800

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Conform Stretch Bandage (5SIZES)

  Class I

  FDA 510(k) K771452 Active Cleared 12 Sep 1977

• Sponge, Curity Washed Gauze

  Class I

  FDA 510(k) K760094 Active Cleared 16 Jul 1976

• Micronet Light Dressing Sponge

  Class I

  FDA 510(k) K780408 Active Cleared 22 Mar 1978

• Urine Specimen Collecting Device

  Class II

  FDA 510(k) K772133 Active Cleared 28 Nov 1977

• Tender-Sorb Drain Sponges

  Class I

  FDA 510(k) K802225 Active Cleared 26 Sep 1980

• Curity Peakometer

  Class II

  FDA 510(k) K771655 Active Cleared 14 Oct 1977

See all devices from Kendall Research Center →