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510(k) K823667

CERVICAL COLLAR by Warm & Form, Orthopedic Materials — Product Code IQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1982
Date Received
December 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Cervical
Device Class
Class I
Regulation Number
890.3490
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 IQK

  • K930730 — DORMIE NECK SUPPORT SYSTEM (July 22, 1993)
  • K926291 — SCHUL-TEC IMMOBILIZER (March 30, 1993)
  • K896042 — MEDICAL DISPOSABLE BEDDING (January 10, 1990)
  • K895477 — NOVA PILLOW (January 10, 1990)
  • K882264 — BATTLE CREEK PILLOW (August 9, 1988)
  • K850465 — CERVICAL COLLARS & HEAD HALTERS (April 25, 1985)
  • K832990 — STIFNICK IMMOBILIZING COLLAR (November 7, 1983)
  • K832001 — HEAD-IMMOBILIZER (July 12, 1983)
  • K831582 — VARI-SUPPORT NECK POSTURE PILLOW (June 15, 1983)
  • K830348 — VINYL EXTRICATION COLLAR (March 9, 1983)