Home / 510(k) Clearances / K830243

510(k) K830243

ABDUCTION PILLOW by Warm & Form, Orthopedic Materials — Product Code IOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1983
Date Received
January 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Abduction, Congenital Hip Dislocation
Device Class
Class I
Regulation Number
890.3665
Review Panel
PM
Submission Type

Other clearances by Warm & Form, Orthopedic Materials

  • K830245 — HEAD HALTER (March 9, 1983)
  • K830244 — TRACTION ACCESSORIES (March 9, 1983)
  • K830246 — CAST SHOE, CAST BOOT (February 18, 1983)
  • K823658 — DELUXE KNEE IMMOBILIZER(UNIVERSAL) (December 30, 1982)
  • K823663 — ABDOMINAL BINDER (December 30, 1982)
  • K823666 — UNIVERSAL WRIST SPLINT & FOREARM SPLINT (December 30, 1982)
  • K823660 — UNIVERSAL BUCKS TRACTION (December 30, 1982)
  • K823662 — RIB BELT (UNIVERSAL) (December 30, 1982)
  • K823665 — ROTATION BOOT (December 30, 1982)
  • K823659 — PELVIC TRACTION BELT (December 30, 1982)

Other clearances for product code IOZ

  • K823820 — ABDUCTION PILLOW (January 14, 1983)
  • K810557 — HIP ABDUCTION SPLINT (March 13, 1981)
  • K780375 — PAVLIK HARNESS (March 15, 1978)