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510(k) K812349

HAND SPLINTS & COMPONENTS by Fred Sammons, Inc. — Product Code ILH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1981
Date Received
August 18, 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 Fred Sammons, Inc.

  • K880644 — ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) (May 6, 1988)
  • K880647 — ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) (April 1, 1988)
  • K831549 — ARM SLINGS (June 30, 1983)
  • K831548 — SPLINTS (June 27, 1983)
  • K831544 — DELUXE TRACTION EXERCISE GLOVE BK5035 (June 24, 1983)
  • K831543 — ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (June 24, 1983)
  • K831550 — FINGER BONIOMETER BK7506 (June 24, 1983)
  • K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE (June 24, 1983)
  • K831553 — LEG DRAINAGE BAG STRAP BK6011 (June 16, 1983)
  • K831547 — RAISED TOILET SEATS & NAIL CLIPPERS (June 8, 1983)

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