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510(k) K810111

CELLONA PLASTER VARNISH by Secol Co. — Product Code ITG

K810111 is an FDA 510(k) premarket notification submitted by Secol Co. for the device "CELLONA PLASTER VARNISH". The FDA issued a decision of Substantially Equivalent on February 4, 1981. The device falls under product code ITG (Bandage, Cast), a Class I device regulated under 21 CFR 890.3025. Secol Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1981
Date Received
January 16, 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 Secol Co.

  • K802790 — SOLVALINE (February 13, 1981)
  • K810110 — COBBLER'S CHIP SPLINTS (January 26, 1981)
  • K810109 — METAL SPLINTS (January 26, 1981)
  • K802794 — PRO-OPHTA STICKS (December 22, 1980)
  • K802793 — LOMATUELL OINTMENT DRESSING (December 18, 1980)
  • K802786 — POROPLAST-EYE DRESSING (December 17, 1980)
  • K802787 — METALLINE DRESSINGS (December 17, 1980)
  • K802797 — O.R. DRAPES (December 17, 1980)
  • K802791 — ZINC PASTE BANDAGE (December 17, 1980)
  • K802799 — EYE PADS (December 17, 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