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510(k) K832144

SPLINT WOOD by Vermont Wood Industries, Inc. — Product Code ILH

K832144 is an FDA 510(k) premarket notification submitted by Vermont Wood Industries, Inc. for the device "SPLINT WOOD". The FDA issued a decision of Substantially Equivalent on August 1, 1983. The device falls under product code ILH (Splint, Hand, And Components), a Class I device regulated under 21 CFR 890.3475.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1983
Date Received
June 30, 1983
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 for product code ILH

  • 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)
  • K821637 — WIRE-FOAM MP FLEXION SPRING (June 11, 1982)

FDA data resources