Home / 510(k) Clearances / K831548

510(k) K831548

SPLINTS by Fred Sammons, Inc. — Product Code ILH

K831548 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "SPLINTS". The FDA issued a decision of Substantially Equivalent on June 27, 1983. The device falls under product code ILH (Splint, Hand, And Components), a Class I device regulated under 21 CFR 890.3475. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1983
Date Received
May 12, 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 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)
  • K831550 — FINGER BONIOMETER BK7506 (June 24, 1983)
  • K831543 — ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (June 24, 1983)
  • K831544 — DELUXE TRACTION EXERCISE GLOVE BK5035 (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)
  • K831552 — SORBOTHANE VISCO INNER SOLE PAD (June 8, 1983)

Other clearances for product code ILH

  • K832144 — SPLINT WOOD (August 1, 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)
  • K821637 — WIRE-FOAM MP FLEXION SPRING (June 11, 1982)

FDA data resources