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510(k) K810877

ORTHOSIS BANDAGES by Ortho-Cast, Inc. — Product Code ITG

K810877 is an FDA 510(k) premarket notification submitted by Ortho-Cast, Inc. for the device "ORTHOSIS BANDAGES". The FDA issued a decision of Substantially Equivalent on April 17, 1981. The device falls under product code ITG (Bandage, Cast), a Class I device regulated under 21 CFR 890.3025.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1981
Date Received
March 31, 1981
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 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