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510(k) K800749

IPOCON 7 by Ipos Luneburg — Product Code ITG

K800749 is an FDA 510(k) premarket notification submitted by Ipos Luneburg for the device "IPOCON 7". The FDA issued a decision of Substantially Equivalent on July 28, 1980. The device falls under product code ITG (Bandage, Cast), a Class I device regulated under 21 CFR 890.3025. Ipos Luneburg has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1980
Date Received
April 4, 1980
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 Ipos Luneburg

  • K834143 — NYLON COMPRESSION STUMP SHEATH (January 9, 1984)
  • K833868 — IPOS G.L.P. SYSTEM (November 28, 1983)
  • K831690 — IPOS ANTI-ADDUCTUS SHOE (June 24, 1983)
  • K802976 — CARBONACRYL (December 19, 1980)
  • K802977 — IPOCARBON STRETCH STOCKINETTE (December 19, 1980)
  • K800716 — ORTHOTIC LEG GAIT CORRECTOR DEVICE (May 2, 1980)
  • K800715 — OHC DYNAMIC CLUB FOOT BRACE (May 2, 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