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510(k) K810109

METAL SPLINTS by Secol Co. — Product Code ILH

K810109 is an FDA 510(k) premarket notification submitted by Secol Co. for the device "METAL SPLINTS". The FDA issued a decision of Substantially Equivalent on January 26, 1981. The device falls under product code ILH (Splint, Hand, And Components), a Class I device regulated under 21 CFR 890.3475. Secol Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1981
Date Received
January 16, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Hand, And Components
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances by Secol Co.

  • K802790 — SOLVALINE (February 13, 1981)
  • K810111 — CELLONA PLASTER VARNISH (February 4, 1981)
  • K810110 — COBBLER'S CHIP 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)
  • K802799 — EYE PADS (December 17, 1980)
  • K802791 — ZINC PASTE BANDAGE (December 17, 1980)
  • K802797 — O.R. DRAPES (December 17, 1980)

Other clearances for product code ILH

  • K832144 — SPLINT WOOD (August 1, 1983)
  • K831548 — SPLINTS (June 27, 1983)
  • K823644 — FINGER FLEXION SPLINT (January 21, 1983)
  • K823647 — FINGER EXTENSION SPLINT (January 21, 1983)
  • K823666 — UNIVERSAL WRIST SPLINT & FOREARM SPLINT (December 30, 1982)
  • K823601 — WRIST SUPPORT (December 22, 1982)
  • K823393 — STAX FINGER SPLINTS (December 3, 1982)
  • K823165 — WRIST SPLING & FOREARM SPLINT (November 16, 1982)
  • K822651 — TOTAL FINGER FLEXION SPLINT (September 17, 1982)
  • K821635 — SOFT ULNAR DEVIATION SPLINTS (June 11, 1982)

FDA data resources