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510(k) K823165

WRIST SPLING & FOREARM SPLINT by Warm & Form, Orthopedic Materials — Product Code ILH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1982
Date Received
October 25, 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 Warm & Form, Orthopedic Materials

  • K830244 — TRACTION ACCESSORIES (March 9, 1983)
  • K830245 — HEAD HALTER (March 9, 1983)
  • K830243 — ABDUCTION PILLOW (March 8, 1983)
  • K830246 — CAST SHOE, CAST BOOT (February 18, 1983)
  • K823658 — DELUXE KNEE IMMOBILIZER(UNIVERSAL) (December 30, 1982)
  • K823663 — ABDOMINAL BINDER (December 30, 1982)
  • K823660 — UNIVERSAL BUCKS TRACTION (December 30, 1982)
  • K823662 — RIB BELT (UNIVERSAL) (December 30, 1982)
  • K823666 — UNIVERSAL WRIST SPLINT & FOREARM SPLINT (December 30, 1982)
  • K823665 — ROTATION BOOT (December 30, 1982)

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)
  • K822651 — TOTAL FINGER FLEXION SPLINT (September 17, 1982)
  • K821637 — WIRE-FOAM MP FLEXION SPRING (June 11, 1982)
  • K821635 — SOFT ULNAR DEVIATION SPLINTS (June 11, 1982)