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510(k) K771452

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

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

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  • K780062 — CATHETER/HEMOSTATIC/GERIATRIC (February 14, 1978)
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  • 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

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  • 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)