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510(k) K832990

STIFNICK IMMOBILIZING COLLAR by Laerdal California, Inc. — Product Code IQK

K832990 is an FDA 510(k) premarket notification submitted by Laerdal California, Inc. for the device "STIFNICK IMMOBILIZING COLLAR". The FDA issued a decision of Substantially Equivalent on November 7, 1983. The device falls under product code IQK (Orthosis, Cervical), a Class I device regulated under 21 CFR 890.3490. Laerdal California, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1983
Date Received
September 1, 1983
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 Laerdal California, Inc.

  • K941578 — STATVAC PORTABLE SUCTION UNIT (May 18, 1994)
  • K922842 — STYLET AND TRACHEAL LIGHTWAND (STL) (December 18, 1992)
  • K862875 — E-VAC(TM) (November 3, 1986)
  • K843790 — TRACHEAL TUBE FIXATION DEVICE (March 11, 1985)

Other clearances for product code IQK

  • K930730 — DORMIE NECK SUPPORT SYSTEM (July 22, 1993)
  • K926291 — SCHUL-TEC IMMOBILIZER (March 30, 1993)
  • K895477 — NOVA PILLOW (January 10, 1990)
  • K896042 — MEDICAL DISPOSABLE BEDDING (January 10, 1990)
  • K882264 — BATTLE CREEK PILLOW (August 9, 1988)
  • K850465 — CERVICAL COLLARS & HEAD HALTERS (April 25, 1985)
  • K832001 — HEAD-IMMOBILIZER (July 12, 1983)
  • K831582 — VARI-SUPPORT NECK POSTURE PILLOW (June 15, 1983)
  • K830348 — VINYL EXTRICATION COLLAR (March 9, 1983)
  • K830351 — DISPOSABLE EXTRICATION COLLAR (March 9, 1983)

FDA data resources