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510(k) K820382

FROG SPLINT by Conco Medical Co. — Product Code ILH

K820382 is an FDA 510(k) premarket notification submitted by Conco Medical Co. for the device "FROG SPLINT". The FDA issued a decision of Substantially Equivalent on March 1, 1982. The device falls under product code ILH (Splint, Hand, And Components), a Class I device regulated under 21 CFR 890.3475. Conco Medical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1982
Date Received
February 9, 1982
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 Conco Medical Co.

  • K904819 — SHUR-LOCK ICE WRAP SYSTEM (December 6, 1990)
  • K821701 — RAPIDO-LASTIC IN STERILE FORM (July 22, 1982)
  • K820826 — STAX FINGER SPLINT (April 8, 1982)
  • K820380 — CURVED FINGER SPLINT (March 1, 1982)
  • K820381 — FINGER PROTECTOR (March 1, 1982)
  • K820383 — FINGER COT (February 24, 1982)
  • K760140 — BANDAGE, WRINKY-LASTIC ELASTIC GAUZE (July 19, 1976)
  • K760139 — BANDAGE, E-COTTON ELASTIC (July 19, 1976)
  • K760142 — BANDAGE, RAPIDO-LASTIC COTTON/NYLON (July 19, 1976)
  • K760141 — BANDAGE, CONFO-LASTIC ALL COTTON ELASTIC (July 19, 1976)

Other clearances for product code ILH

  • K832144 — SPLINT WOOD (August 1, 1983)
  • K831548 — SPLINTS (June 27, 1983)
  • K823647 — FINGER EXTENSION SPLINT (January 21, 1983)
  • K823644 — FINGER FLEXION 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