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510(k) K811164

URETHANE ORTHOPAEDIC CASTING TAPE by Hexcel Medical — Product Code ITG

K811164 is an FDA 510(k) premarket notification submitted by Hexcel Medical for the device "URETHANE ORTHOPAEDIC CASTING TAPE". The FDA issued a decision of Substantially Equivalent on May 27, 1981. The device falls under product code ITG (Bandage, Cast), a Class I device regulated under 21 CFR 890.3025. Hexcel Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1981
Date Received
April 28, 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 by Hexcel Medical

  • K840416 — HEXCELITE (March 23, 1984)
  • K820890 — URETHANE ORTHOPAEDIC CASTING TAPE (June 23, 1982)
  • K812669 — SEATTLE II TOTAL HIP SYSTEM (October 2, 1981)
  • K812687 — BRIGHAM II TOTAL HIP SYSTEM (October 2, 1981)
  • K812068 — PROPOSED CONTROLS FOR DOSIMETRIC RELEASE (September 8, 1981)
  • K810956 — MARCOVE HUMERAL ROD (April 17, 1981)
  • K810957 — MARCOVE INTRAMEDULLARY ROD (April 17, 1981)
  • K810230 — CONDYLAR KNEE W/METAL ENCAPSULATED TIB (March 6, 1981)
  • K800051 — HEXCEL FEMORAL COMPONENT HIP PROSTHESIS (January 28, 1980)
  • K800050 — ANITOMIC TOTAL HIP SYSTEM (January 24, 1980)

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