Home / 510(k) Clearances / K771452

510(k) K771452

CONFORM STRETCH BANDAGE (5SIZES) by Kendall Research Center — Product Code ITG

K771452 is an FDA 510(k) premarket notification submitted by Kendall Research Center for the device "CONFORM STRETCH BANDAGE (5SIZES)". The FDA issued a decision of Substantially Equivalent on September 12, 1977. The device falls under product code ITG (Bandage, Cast), a Class I device regulated under 21 CFR 890.3025. Kendall Research Center has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1977
Date Received
August 3, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Cast
Device Class
Class I
Regulation Number
890.3025
Review Panel
PM
Submission Type

Other clearances by Kendall Research Center

  • K802225 — TENDER-SORB DRAIN SPONGES (September 26, 1980)
  • K781357 — T.E.D. SEQUENTIAL COMPRESSION SLEEVES (September 20, 1978)
  • K780408 — MICRONET LIGHT DRESSING SPONGE (March 22, 1978)
  • K780062 — CATHETER/HEMOSTATIC/GERIATRIC (February 14, 1978)
  • K780120 — ANESTHESIA TRAY, CAUDAL (February 6, 1978)
  • K772134 — SYRINGE, IRRIGATION, PRE-FILLED (November 28, 1977)
  • K772133 — URINE SPECIMEN COLLECTING DEVICE (November 28, 1977)
  • K771655 — CURITY PEAKOMETER (October 14, 1977)
  • K771079 — CURITY IRRIGATION TRAY (September 15, 1977)
  • K771563 — CONFORM ELASTIC NETTING (September 12, 1977)

Other clearances for product code ITG

  • K873111 — CONFORMA(TM) PLASTER BANDAGES (October 9, 1987)
  • K862115 — DEKNA BAND KIT (August 19, 1986)
  • K842573 — T.P.G. CAST TAPE (August 10, 1984)
  • K840416 — HEXCELITE (March 23, 1984)
  • K833732 — NON WETTING UNDERCAST PADDING (December 12, 1983)
  • K832992 — SOFFBAN ORTHOPEDIC PADDING (November 14, 1983)
  • K832237 — ORTHOPEDIC CASTING TAPE MAXCAST (August 16, 1983)
  • K830650 — SUPPORT PRODUCTS EXAMPLE PROSET CAST (July 7, 1983)
  • K831492 — YESONA PLASTER OF PARIS BANDAGE (June 30, 1983)
  • K820890 — URETHANE ORTHOPAEDIC CASTING TAPE (June 23, 1982)

FDA data resources